Careers with Cirtec – Medical Device Design, Manufacturing, and Finished Device Assembly

We actively seek creative candidates in the fields of sales, program management, mechanical engineering, quality engineering, electronics and software engineering, process engineering, and manufacturing engineering, including technicians, assemblers and supervisors. Our employees have the satisfaction of knowing that the work they do is helping patients live better, longer lives, and they take pride in the work they perform for one of the industry’s top medical device companies. Here at Cirtec, every employee is highly valued and crucial to our success. We place a high value on performance excellence, career development, safety, rewards and communication. Cirtec has rewarding opportunities where you can make a difference. To view all current positions and apply online, visit the Cirtec Career Center:

If you value teamwork, client focus, accountability and innovative thinking, Cirtec is the place for you! We want to be your career choice in the Medical Device Industry. Cirtec is an equal opportunity employer and does not discriminate based on race, gender, ethnicity or sexual orientation.

Opportunities in Brooklyn Park, MN

Industrial Engineer

Summary:

The Operational Excellence program seeks to minimize waste and variation through Lean and Six Sigma approaches leading to improved production processes and systems that operate at high efficiency levels. The Industrial Engineer (IE) is responsible for identifying and leading execution of a wide range of Continuous Improvement projects.  The IE leads, facilitates, executes, and manages team training initiatives and projects.  The IE will utilize knowledge of COGs, gross margin, facility design, material handling equipment, labor management, staff planning and project management to identify, quantify, prioritize and recommend improvement projects that align with the Operational Excellence team charter and organizational goals and objectives.

Responsibilities:

  • Participates in identification and planning of department goals implementation of initiatives intended to improve quality, cost and delivery
  • Serves as an engaging and collaborative teacher/trainer providing internal standardized lean training and consulting support for Lean & Six Sigma tools, data mining and presentation with heavy emphasis on MS Excel
  • Supports the philosophy of waste reduction through implementation of Lean and Six Sigma approaches within the organization
  • Utilizes tools and methodologies including, but not limited to time studies, line balancing, setup time reductions, line layout creation, flow improvement, 5S, standard work, visual factory improvements and accountability systems
  • Collaborates with cross-functional teams
  • Evaluates, designs, and implements new production line and facility layouts
  • Leads and/or facilitates A3 projects and teams
  • Collaborates with others on Key Process Indicator development and implementation
  • Seeks out continuous improvement opportunities, weighs their value based on benefit, investment, and risk, and prioritizes work accordingly
  • Participates in project work to help customers and operators achieve sustainable results
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS degree in Industrial Engineering highly preferred.  Advanced degree a plus
  • 2-5 years manufacturing experience, preferably in medical device and/or machining.
  • Strong MS Excel knowledge
  • Six Sigma or Lean Certification (ASQ or IASSC) is a plus
  • Strong analytical, problem solving and project management skills
  • Must be a learner; adaptable to accept new changes in the field of lean manufacturing and desire to remain knowledgeable regarding the latest developments in field
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to influence and engage others to accomplish projects
  • Must be a clear communicator of ideas in both written and oral forms to all levels of the organization
  • Strong organizational abilities; can multitask and prioritize to meet deadlines in timely manner
  • Ability to travel to other sites (approximately 5-10%)

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, walk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required:  Must following cleanroom procedures and any other procedures specific to the work area.

WORKING ENVIRONMENT

Work is performed in both office and production environments.   The noise level in the work environment is usually moderate. Must following cleanroom procedures and any other procedures specific to the work area. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Engineer

Summary:

This position is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications and Class III medical device quality standards.  This position recommends and implements improvements to sustained production processes, methods and controls; as well as coordinates the launch of new products into pilot production and the transfer of existing product lines.

Responsibilities:

  • Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
  • Prepares engineering change orders and coordinates the deployment of NPI and Products Transfer changes including training operation team members at the sending and receiving sites.
  • Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
  • Coordinates the manufacturing launch of new and transfer products including establishing yield targets, run rates, training needs and evaluating results.
  • Develop and qualify various tools and equipment required for manufacturing processes.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
  • Utilizing tools associated with risk management (e.g., PFMEA) to identify potential risks and the associated corrective actions.
  • Supporting required equipment qualification and process validations (IQ, OQ and PQ).
  • Troubleshoot manufacturing processes when defects occur.  Determine root cause and implement effective containment and countermeasures.
  • Disposition non-conforming products and develop re-work procedures.
  • Communicate with customers regarding process improvements and production changes.
  • Represent manufacturing on cross functional teams.
  • Participate in Kaizen events and drive continuous improvement efforts.
  • Product Transfer experience a plus.
  • The ability to work and achieve expected results independently.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree in Engineering or related field.
  • Knowledge of manufacturing and assembly processes.
  • Excellent verbal and written communication skills.
  • Fluency in English.
  • Minimum 2-5 years of experience with Class II or III Medical devices, FDA standards, ISO 13485 and GMP principles.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Association with supporting documents including, ECN’s, process deviation, non-conformances, stop shipment notifications and all associated quality related documents.
  • Strong computer skills associated with MS Office suite, Minitab and SolidWorks a plus.
  • Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
  • The ability to understand a range of engineering functions and procedures.
  • Interpersonal, presentation and communication skills.
  • The capacity to work well under pressure and take on new challenges.
  • Organizational and time management skills.
  • Project management skills and the ability to work to tight deadlines.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in an office and manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Travel 20%

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Industrial Engineer

Summary:

This position is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications and Class III medical device quality standards.  This position recommends and implements improvements to sustained production processes, methods and controls; as well as coordinates the launch of new products into pilot production and the transfer of existing product lines.

Responsibilities:

  • Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
  • Prepares engineering change orders and coordinates the deployment of NPI and Products Transfer changes including training operation team members at the sending and receiving sites.
  • Have a core knowledge of and ability to operate within WMS systems and ERP systems to created and update products BOM and routers.
  • Collaborate with facilities in the design of facility layouts using AutoCAD and/or SolidWorks.
  • Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for sustained, transferred and new products.
  • Coordinates the manufacturing launch of new and transfer products including establishing yield targets, run rates, training needs and evaluating results.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
  • Utilizing tools associated with risk management (e.g., PFMEA) to identify potential risks and the associated corrective actions.
  • Evaluate and redesign cell layouts for material flow and handling, containerization, standard quantities, buffering, and visual controls.
  • Perform special Operations NPI and Product Transfer projects as directed by the Operation’s GM and Project Manager.
  • Communicate with customers regarding production changes and product transfer.
  • Represent Project Team on cross functional teams.
  • Participate in Kaizen, 5S and Visual Factory implementations for new, existing and product transfer production lines.
  • Product Transfer experience a plus.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree in Industrial Engineering or similar.
  • Knowledge of manufacturing and assembly processes.
  • Excellent verbal and written communication skills.
  • Fluency in English.
  • Minimum 2-5 years of experience with Class II or III Medical devices, FDA standards, ISO 13485 and GMP principles.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Association with supporting documents including, ECN’s, process deviation, non-conformances, stop shipment notifications and all associated quality related documents.
  • Strong computer skills associated with MS Office suite, Minitab and SolidWorks a plus.
  • Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
  • The ability to understand a range of engineering functions and procedures.
  • Interpersonal, presentation and communication skills.
  • The capacity to work well under pressure and take on new challenges.
  • Organizational and time management skills.
  • Project management skills and the ability to work to tight deadlines.
  • The ability to work and achieve expected results independently.
  • NPI and Product Transfer experience a plus.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in an office and manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those individual encounters while performing the essential functions of this position.

Travel 20%

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Mechanical Design Engineer

Summary:

Defines, develops, and designs medical devices and related accessories.  Owns efforts in developing solutions to product design, and design for manufacturability, translating requirements from the customer into realized products. Able to multitask and run multiple projects while meeting customer commitments.

Responsibilities:

  • Owns the design and development of medical devices through:
    • Transformation of internal and external customer inputs and requirements into results
    • Developing full design requirements, product design, specification creation with mechanical and electrical components and assemblies
    • Creating test methods, design verification and validation activities
    • Generate 3D models and Engineering drawings utilizing Solidworks
    • Sourcing materials for prototype builds
  • Host design reviews with internal and external stakeholders
  • Manage workload to support various projects
  • Maintain compliance to procedures and regulatory requirements
  • Provides regular status updates to management and or customer
  • Writes/updates work instructions, part specifications, verification protocols, and various technical documents
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
  • 0-5 years’ experience
  • Proficiency with Solidworks required
  • Solid working knowledge of dimensioning and tolerances, GD&T
  • Computer skills associated with Microsoft software
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Maintains performance with changing priorities under supervision
  • Possess team collaboration skills
  • Strong mechanical aptitude

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Engineering Document Control Specialist

Summary:

Provide support to engineering, production, accounting, sales and quality while adhering to the quality system requirements. This position is responsible for initiating, improving and maintaining the engineering documentation system and contents while identifying continuous improvement projects pertaining to the engineering document system. Activities completed in this position must be implemented in accordance with Good Manufacturing Practices, Good Documentation Practices, ISO and FDA requirements.

Responsibilities:

  • Manage the day-to-day requirements of the engineering documentation system, through:
    • Engineering Change Orders
    • Manufacturing Change Requests
    • Deviations
    • External standard control (i.e., ASTM, ISO)
    • Records Management
    • Documentation Life Cycle (creation, revision, obsolescence)
    • Provides training and guidance
  • Work with product development teams to ensure compliance when transferring documents to the Engineering Document System, make recommendations to properly structure, develop and transfer the documentation
  • Utilizes on site systems to control hard and electronic copies of documents for example: Item Masters, BOM’s, Routers, Travelers, Manufacturing Change Requests, Device Master Records, Inspection Plans, External Standards
  • Identifies improvements for coordinating usage of the documentation systems
  • Creates and Maintains processes for documentation system requirements
  • Represent Engineering Documentation needs in cross functional teams as assigned
  • Maintain compliance to procedures and regulatory requirements
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required
  • Maintains and prepares project plans to satisfy timeline requirements
  • Performs Corrective and Preventative Action tasks
  • Miscellaneous items may include: System Log Maintenance, ECO Creation, Engineering form(s) and Template(s) control, BOM entries, ERP System data entry, Creates/designs forms for improving data accuracy and ease of entry, reviews and finalizes pre-release documentation
  • Other Duties as assigned

Requirements:

  • FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
  • 3 Plus years’ experience in the engineering/manufacturing environment for medical devices related to documentation control
  • Strong computer skills associated with Microsoft software
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Maintains performance with changing priorities under minimal supervision
  • Possess team collaboration skills
  • Must be able to make clear and accurate decisions
  • Proven history of pursuing and driving changes
  • Associates degree in an Engineering discipline or related field
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Process Engineering Manager

Summary:

The Sr. Process Engineering Manager is responsible for a team of over 20 process engineers supporting Cirtec’s Engineering Services organization focused on Implantable Medical Devices and Systems.   Engineering Services encompasses the business processes between customer proposals through design transfer of products to the Manufacturing Organization and is considered the growth vehicle of Cirtec Medical.  This position will be responsible for driving business processes and Standard Operating Procedures (SOPs) associated to how Cirtec executes Process Engineering; ensures the skills of the team meet the requirements of our technology development and customer-driven programs; assures utilization targets of resources are met; drives efficiency of engineering execution to reduce program lead times; and collaborates cross-functionally with Program Management and Functional Leaders to meet the cost, time and performance targets of customer programs.   This role is an important member of the Engineering Services Leadership Team.

Responsibilities:

  • Provide support & supervision to direct reports for the timely completion of projects, initiatives and key activities.
  • Mentor associates and foster a learning and growth environment.  Perform evaluations at regular intervals.
  • Establishes a skill set matrix to identify hard and soft organizational skills needs; ensures redundancy of skills to ensure continuity of capability.
  • Collaborates with Program Management to assess long term resource forecasts and ensure timely hire and on-boarding of personnel to meet the demands of that forecast.
  • Serve as secondary technical contact with clients; instills confidence in our technical capabilities and quality products.
  • Ensure team is performing under the Cirtec quality system and with good engineering practices.
  • In collaboration with Program Management, ensures utilization and efficiency targets for customer billing and engineering execution are met.
  • Ensure that projects stay on schedule and are fully documented as required by medical device regulatory agencies.
  • Oversee the process of developing new or modified products ensuring compliance to internal, regulatory, and customer requirements.
  • Provides input into technology roadmap, advocating for investments in equipment and processes to ensue Cirtec’s capabilities stay ahead of customer needs.
  • Provide leadership for teams that will execute projects in all aspects of the development process to include requirement and specification definition, risk management, design development, process development, sourcing and supply chain, prototype builds, device verification testing, process qualification, and transfer into manufacturing.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree (engineering, biomedical engineering, or related) required, with a related advanced degree preferred.
  • A minimum of ten (10) years previous progressive experience in an engineering or program management roles; three (3) years of experience in leadership roles.
  • Demonstrated ability to lead engineering teams successfully from early-stage development to production.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications and illustrations.
  • Technical report preparation and formal presentation skills.
  • Strong analytical skills must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Exceptional knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.
  • Strong background and demonstrated results in a related “active implant” field (Neuromodulation, Cardiac Rhythm Management, etc.) preferred.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Director and General Manager, Engineering Services

Summary:

The Sr. Director and General Manager (GM) of Engineering Services is fully responsible for a multi-site P&L related to Cirtec’s Engineering Services organization focused on Active Implantable Systems.  Engineering Services encompasses the business processes between customer proposals through design transfer of products to the Engineering Organization and is considered the growth vehicle of Cirtec Medical.  This position directly supervises an organization consisting of approximately 80 personnel across a wide range of program management and engineering disciplines located at 2 different sites.  The GM will maintain overall responsibility for new product development and improvement to existing product development activities; design and develop a differentiated product platform on time and within budget based on customer design specifications; accountable for the evaluation and implementation of timely and efficient project plans, product mapping, budget planning and anticipated product launches; supervise roadmaps and execution for technology development and product transfers.  Particular focus will be placed on customized product development and design-for-manufacturability, to meet the needs of customers. The GM will be an important member of the senior leadership team, playing a vital role in the development of company/corporate objectives and policies, and the achievement of business goals.

Responsibilities:

  • Drives the P&L of Global Engineering to ensure profitability goals are obtained.
  • Develop, execute and maintain short- and long-term strategic plans in support of custom product development and existing company product improvements.
  • Immediately and continuously evaluate and develop methods, techniques, projects, and related programs to ensure on time and within budget achievement of corporate and departmental objectives.
  • Determine appropriateness of overall technology portfolio to achieve agreed objectives.
  • Contribute to the management of the patent portfolio; recommend priority for patent filings.
  • Provide strategic leadership and insight, ensuring the development and goal achievement of a highly effective engineering team.
  • Provide technical, logistical and planning guidance to resolve all product development issues.
  • Ensure cost effective measures and budget compliance; develop cost saving initiatives to meet or exceed financial performance requirements.
  • Partner cross-functionally in support of organizational goals and objectives.
  • Maintain knowledge of Good Manufacturing Practices (GMP), ISO-13485 and related regulations and Standard Operating Procedures (SOPs) as appropriate.
  • Ensure continual regulatory and quality compliance.
  • Maintain up-to-date knowledge of industry trends, new technologies, and competitor business; evaluate and adopt recent developments in appropriate scientific field for new product potential and improvement of existing products.
  • Other responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree (engineering, biomedical engineering, or related) required, with a related advanced degree preferred.
  • A minimum of fifteen (15) years previous progressive experience in manufacturing, product development and program management experience (at least five years’ experience at a senior leadership level).
  • Strong background and demonstrated results in a related “active implant” field (Neuromodulation, Cardiac Rhythm Management, etc.)
  • Demonstrated success in organizational development and driving results in a fast-growing enterprise
  • Experienced in budgeting, forecasting and driving improvement in financial performance with budgets in excess of $1 million required.
  • Record of successful late-stage product development and subsequent product launch.
  • Superior communication skills and demonstrated negotiation abilities.
  • Superior knowledge and leadership skills with various project planning and management methodologies.
  • Strong focus on collaboration and teamwork.
  • Demonstrated success implementing projects or solving issues that significantly impact the overall success of an organization.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Engineer

Summary:

This position is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications and Class III medical device quality standards.  This position recommends and implements improvements to sustained production processes, methods, and controls; as well as coordinates the launch of new products into pilot production.

Responsibilities:

  • Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
  • Prepares engineering change orders and coordinates the deployment of changes including training operation team members.
  • Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
  • Coordinates the manufacturing launch of new products including establishing yield targets, run rates, training needs, and evaluating results.
  • Develop and qualify various tools and equipment required for manufacturing processes.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
  • Utilizing tools associated with risk management (e.g., PFMEA) to identify potential risks and the associated corrective actions.
  • Supporting required equipment qualification and process validations (IQ, OQ and PQ).
  • Troubleshoot manufacturing processes when defects occur.  Determine root cause and implement effective containment and countermeasures.
  • Disposition non-conforming products and develop re-work procedures.
  • Communicate with customers regarding process improvements and production changes.
  • Represent manufacturing on cross functional teams.
  • Participate in Kaizen events and drive continuous improvement efforts.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree in Engineering or related field.
  • Knowledge of manufacturing and assembly processes.
  • Excellent verbal and written communication skills.
  • Fluency in English.
  • Minimum 2-5 years of experience with Class II or III Medical devices, FDA standards, ISO 13485 and GMP principles.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Association with supporting documents including, ECN’s, process deviation, non-conformances, stop shipment notifications and all associated quality related documents.
  • Strong computer skills associated with MS Office suite, Minitab, and SolidWorks a plus.
  • Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
  • The ability to understand a range of engineering functions and procedures.
  • Interpersonal, presentation and communication skills.
  • The capacity to work well under pressure and take on new challenges.
  • Organizational and time management skills.
  • Project management skills and the ability to work to tight deadlines.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in an office and manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality System Specialist

Summary:

Responsible for ensuring operational adherence and compliance to Cirtec Medical’s Quality Management System (QMS) requirements. Ensure compliant execution and coordination of system elements within the Quality Systems & Control functions team.

Responsibilities:

  • Knowledge of identification, traceability, containment, and segregation requirements for handling of NCM.
  • Knowledge of the Materials Review Board (MRB) responsibilities and process for handling of NCM.
  • Knowledge of process(es) for investigation/analysis of returned/complaint materials.
  • Coordinate activities related to NCM, Complaint, RMA, and CAPA processes.
  • Knowledge and experience conducting investigation and root cause analysis of advanced/complex issues.
  • Experience examining the data for patterns and trends and working on cross-functional teams.
  • Escalate material nonconformances to CAPA system based on trending and monitoring analysis.
  • Communicate product performance by formal presentations to management committees.
  • Maintain quality system documents related to NCMR, CAPA, and Complaint systems.
  • Consistently abides by and conforms to all established Cirtec Medical policies and procedures.
  • Completes assigned tasks while operating independently and/or with minimal supervision.
  • Responds and adapts to changing priorities with minimal disruption.
  • Act as a CAPA Owner or support CAPA activities, as necessary, driving corrections and corrective actions to successful completion.
  • Provide support to the Supplier Quality management group as needed.
  • Provide support during internal audit and external audits.
  • Ensure adherence to training requirements regarding Quality Management System elements, controls, processes and procedures.
  • Provide training, as needed, to individuals or groups on NCM Control, CAPA, etc.
  • Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System and its requirements.
  • Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidelines and rules.
  • Support Corporate Quality Management System initiatives and continuous improvement activities.
  • Ensure compliance to regulatory standards and requirements as applicable.
  • Ensure compliance of all site personnel to Corporate and site-level QMS and functional training requirements.
  • Adhere to professional workplace attire, time, attendance and leave of absence policies.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Associated/Bachelor of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred)
  • Minimum of 2-4 years of experience in a regulated manufacturing environment required
  • Advanced Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred)
  • Quality certification(s) (e.g. ASQ CQT, CQI, etc.)
  • Class I, II and/or III Medical Device manufacturing experience
  • Other regulated manufacturing industry experience (e.g. Aerospace, Automotive, Defense, Pharmaceutical, etc.)
  • Knowledge of, and experience with, GMP/ISO Standards
  • Strong verbal and written English language communication skills
  • Must be able to successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements as provided
  • Must demonstrate ability and/or experience in computer use and general office software – Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint)
  • “Hands-on” self-starter with ability to work both independently and as part of a team
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk for long periods of time.   The employee may be required to lift 50 pounds without restriction. May be required to work overtime and/or flexible hours, including weekends, nights and holidays based on special projects and/or critical situational business priorities. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Machinist II - Milling

Summary:

Hours & Shifts:
1st shift is Monday – Thursday from 5:00 AM – 3:30 PM
2nd shift is Monday – Thursday from 3:30 PM – 2:00 AM

This position is primarily responsible to maintain simple set-ups on CNC machinery and have a good working knowledge of the machine he/she is working on.  Must exhibit the ability to produce quality workmanship consistently.

Responsibilities:

  • Accurately completes all department paperwork including job travelers, Inspection documentation, work packet information, and tooling request forms
  • Builds quality parts using good working knowledge of blueprints
  • Understands, embraces and follows Cirtec Medical workmanship specs
  • May be required to change tool depending upon the job schedule
  • Actively participates in improving quality programs and team meetings
  • Uses knowledge of the functions of the machines, including tool and work offsets, to adjust them to ensure quality
  • Regularly inspects parts according to process to ensure quality parts are being produced
  • Properly uses all equipment and maintains a clean work area
  • Uses inspection equipment as required
  • Solves problems of quality and efficiency working within the team
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or G.E.D. Certificate required
  • Two-year technical degree in Machine Technology or equivalent preferred
  • Experience as a CNC Machinist or CNC education required
  • Minimum 2 years of experience programming and operating CNC machine equipment preferred
  • Ability to interpret blueprints, shop drawings, sketches or other production orders
  • Maintain routine production records
  • Knowledge of trade tools, equipment, materials, micrometer, as well as methods and techniques used in safe machining operations
  • Ability to use precision tools (e.g. calipers) to take accurate measurements
  • Strong attention to quality and detail orientation
  • Mechanical aptitude
  • Mathematical skills
  • Ability to work independently
  • Time management skills to meet schedules and time standards, to best of ability as instructed
  • Strong interpersonal skills to establish and maintain cooperative and effective working relationships
  • Basic understand of geometric dimensions and tolerancing (GD&T), GMP and GDP
  • On-going skills training

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Machinist II - Swiss

Summary:

Hours & Shifts:
1st shift is Monday – Thursday from 5:00 AM – 3:30 PM
2nd shift is Monday – Thursday from 3:30 PM – 2:00 AM

The Machinist II is knowledgeable with all machine functions. This position is a production position that requires the machinist to be able to set up, adjust and understand the programming of CNC machines. This position requires the operator to perform a series of progressive machining operations on repetitive work to close and exacting tolerances and finish specification. At this level the machinist needs to be able to check parts for conformance to specifications, set up new and repeat jobs, troubleshoot issues, and make program edits.

Responsibilities:

  • Adheres to Cirtec’s Core Values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
  • Operates and sets up CNC shop equipment.
  • Change or replace tooling as needed to maintain tolerances.
  • Monitors and adjusts assigned equipment to ensure dimensional part accuracy.
  • Able to preset tooling for setups and tool breakages during normal operations.
  • Maintains tooling following established tool life guidelines.
  • Troubleshoots and corrects problem with minimal assistance.
  • Deburrs, buffs or sands parts to meet requirements to print specifications.
  • Inspects parts visually and dimensionally using basic inspection equipment and techniques to assure conformance to requirements with minimal assistance.
  • Completes all applicable documentation for current operations.
  • Practices 5S principles daily.
  • Performs other functions as required.

Qualifications:

  • 5+ years CNC machining experience in all phases of machining.
  • Ability to read, interpret and understand blueprints.
  • Ability to work with small precision parts to very close tolerances.
  • Ability to understand and follow through with verbal or written instructions.
  • Dexterity, hand, and eye coordination.
  • Attention to detail.
  • Strong problem-solving skills.
  • Ability to prioritize work and manage multiple tasks.
  • Ability to take direction from the area manager.
  • Ability to collaborate and assist team members, provide input to the area lead, and attend and participate in meetings.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Project Manager

Summary:

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

The Project Manager, based out of our headquarters in Brooklyn Park, MN, will be responsible for managing and coordinating development and manufacturing transfer of complex components and finished medical devices.

Responsibilities:

  • Manages and coordinates development and manufacturing transfer of complex components, sub-assemblies and finished medical devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute project activities based on well-defined prioritization.
  • Coordinates activities across different functional groups to ensure successful completion of project goals and milestones.
  • Tracks project health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders.
  • Proactively anticipates project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
  • Creates and maintains Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements.
  • Supports project team in establishing and maintaining product requirements and test plans.
  • Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
  • Manages internal resource allocation to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum BS in a relevant engineering discipline with at least 5 years of experience within the medical device industry
  • Minimum 2 years of experience in project / program management of medical device development
  • Experience with metals processing and Nitinol-based devices preferred but not required
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control
  • Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents
  • Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders
  • Must have proficiency in MS Project and other MS Office software
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
  • Willingness to travel, if required

Physicial Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Program Manager

Summary:

This position is primarily responsible for executing the project plan and managing the project initiative to established budget and timeline. Coordinate the design, development, documentation, schedules, and validation of moderately complex new and modified customer products.

Responsibilities:

  • Organize a project plan for moderately complex projects to satisfy milestones and deadlines with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets internally and externally.
  • Serve as principal contact with clients.   Coordinate and direct site visits, conference calls, and day-to-day customer communication.
  • Coordinate development, validation and documentation of new products and expansion of existing products, including defining requirements, timelines, and deliverables. This may include engineering support of manufacturing operations for some products.
  • Proactively monitor the performance of assigned projects to budget and schedule to identify trends or project challenges that may impact budget and timeline. Recommend and implement corrective actions.
  • Oversee the process of preparing new or modified products ensuring compliance to internal and client requirements for project completion or testing and manufacturing transfer.
  • Author planning documents as required to support assigned projects.
  • Contribute to quality, design, and development activities or act as backup to engineers on assigned projects as required.
  • Assist business development with definition of project scope, timeline, and budget to support preparation of proposals, quotations, and change orders for clients.
  • Manage resources assigned to the project team to meet project goals/milestones.  Work with management to ensure project has proper resources assigned.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Willingness to travel, if required.
  • Required to maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • A Bachelors’ degree in an engineering discipline with two years of relevant experience or equivalent.
  • Experience in an engineering/manufacturing environment with mechanical, tool design and manufacturing processes preferred.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

Physicial Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Software Development Engineer-National Instruments LabVIEW

Summary:

We are seeking a software developer interested in applying their National Instruments LabVIEW development skills in the area of medical device manufacturing. This position will develop code to verify and validate the operation of active and passive implantable/external medical devices, and mobile applications. This individual will work with a multi-disciplinary engineering team including software, electrical and mechanical hardware engineers and all other functions of the company to ensure high quality and on-time product introductions. This team player will have experience with multi-tasking in a high energy fast paced environment. The person needs to have strong self-starting qualities to independently manage their participation in multiple projects to ensure timely and successful completion. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, and communication.

Responsibilities:

  • Utilize the National Instruments suite of tools (LabVIEW, NI TestStand, NI Unit Test Framework, LVOOP, LabVIEW RT, GOOP, NI Vision Builder) to create and update computer-based test systems.
  • Create interfaces to Medical Implant Communication System (MICS) base stations and implants.
  • Create and review test software requirements
  • Architect, develop and execute the test code.
  • Develop user and system documentation.
  • Participate in product development meetings and software/hardware design and risk analysis reviews.
  • Experience in creating and executing test cases and scripts to verify software and hardware requirements.
  • Working knowledge of testing active and passive implantable/external medical devices; mobile applications and embedded medical devices.
  • Specify and assemble hardware for test stations.
  • Ensure that medical device components are compliant with applicable international standards and requirements.
  • Maintain software/hardware design history file and participate in periodic phase reviews.
  • Report defects to the stakeholders and create test logs.
  • Provide inputs to the team in order to improve the medical device design and test outcomes.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • 3 years of experience with National Instruments LabVIEW suite of tools.
  • Working knowledge in electronics; analog, power and digital, oscilloscopes, and general electronic test equipment.
  • Good communication and interpersonal skills.
  • Excellent oral, written, and presentation communication skills.
  • Bachelor’s Degree preferable in Electrical/Electronic/Biomedical/Computer Engineering OR extensive professional experience in medical device testing.

PREFERRED QUALIFICATIONS

  • 3-7 years’ experience in testing active implantable devices, hand-held devices and test equipment used for medical devices.
  • Experience with the medical device IQ, OQ, PQ test stand progression.
  • Familiarity with medical development standards such as IEC 60601-1, 62304, 60601-1-2, ISO 14708-1, 14708-3.
  • SysML, UML and MBSE.
  • Knowledge of Quality Control principles and methodology.

Physicial Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Quality Engineer

Summary:

This position is primarily responsible for monitoring and auditing the quality of all manufactured goods in a medical device industry. Will work to not only find defects, but also to find the cause of the defect and develop a solution. Interact with customers and suppliers in support of engineering projects.

Responsibilities:

  • Provide Quality Engineering support for engineering project development.
  • Provide Quality Project Management support as needed for product transfers from development to validation.
  • Validation System Owner responsible for the development and management of the validation master plan along with the validation determination.
  • Develop and maintain Validation Standard Operating Procedures.
  • Develop and maintain project Quality Plan for assigned projects.
  • Develop protocols, perform statistical analyses, and write reports for validations and formal process development, which requires quality-engineering involvement such as DOEs.
  • Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
  • Provide Quality Engineering support for manufacturing.
  • CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures.
  • Interact with customers and suppliers to resolve CAPA investigations and in support of manufacturing.
  • Provide Quality Support for the disposition of material.
  • Provide Quality Project Management Support as needed for product transfers from validation to production.
  • Vendor approval and maintain and assess vendor performance data (i.e. SCAR/on time).
  • Review and document procedure changes for quality requirements and compliance with the quality system.
  • Develop quality systems and procedures as needed.
  • Audit support for third party audits, customer audits and internal audits.
  • Support the implementation of continuous improvement initiatives for production processes.
  • Develop and maintain production quality control plans.
  • Initiate and maintain SPC (Statistical Process Control) for production processes.
  • Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable.
  • Comply with all work rules including those pertaining to safety, health, quality and Cirtec policies.
  • Back up to Quality Systems Administrator.
  • Perform other duties as necessary.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Analyze and process Information, Promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Supports Innovation.
  • Bachelors of Science or equivalent, preferably in an engineering discipline.
  • Minimum experience in medical/manufacturing environment: 2 years (BS) OR 4 years (AS) OR 7 years (ND).
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
  • Must possess excellent verbal communication, organizational and management skills.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT:

Work is performed in an office and manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Facilities Technician II

Summary:

Ensure that all facility systems operate optimally to mitigate negative impacts to customer service, quality operations, engineering and any/all other Cirtec BP internal customers. Primary responsibilities include monitoring, maintaining, operating and general oversight of facility systems, equipment, building and grounds.  Provide general facility services to internal customers to ensure optimal customer service. Assist with projects as assigned regarding design, planning, installation, operations, removal, commissioning, qualifications, and documentation.  Assist with developing, refining, and updating preventative and predictive maintenance procedures and documentation. Work directly with contracted services as assigned.

Responsibilities:

  • Perform routine facility work tasks as required to meet internal customer service needs.
  • Collaborate consistently and effectively with EHS to ensure a safe and clean working environment.
  • Perform assembly, installation, removal, testing, calibration, and maintenance of facility equipment and systems.
  • Assist with facility project planning, definition, implementation, execution, and completion of tasks.
  • Document, analyze and communicate work performed, actions, irregularities, and continuous improvement needs.
  • As needed, act as point of contact for outside contractors regarding facility equipment or systems scheduling, planning and work.
  • Assist with developing, documenting, deploying, and sustaining the predictive and preventive facilities maintenance program.
  • Assist with maintaining equipment parts and supplies inventories.
  • Provide professional communications to internal customers, contractors, suppliers, and vendors.
  • Ability to promote the company’s goals of quality, customer service and continuous improvement through employee engagement.

Requirements:

To perform this job successfully, an individual must be able to satisfactorily perform each essential duty and other duties as assigned.

  • Experience:  Associate degree in a technical field such i.e. Mechatronics, Electronics Technology, Electrical Systems, Computerized Control Systems, or Industrial Maintenance Technician is preferred.  Alternatively, 5 or more years related manufacturing mechanical maintenance experience and/or maintenance of facility systems equipment.
  • Professionalism: Consistent performance as a professional, effective, and positive member of the department and organization.
  • Communication:  Strong verbal and written communication skills; ability to interact effectively with all team members, management, internal customers, contractors, suppliers, vendors, and engineering.
  • Schedule:  Flexibility to alter or adjust work schedules or locations is required in order to meet the demands of the business.
  • Emergency Schedule: The ability to respond to on-call emergencies is required.
  • Skills: Ability to confidently and accurately utilize a wide range of core facility maintenance, industrial repair, and/or trade skills
  • Time Management: Organization and prioritization skills; ability to manage multiple priorities based on business needs.  Skill with risk assessment and mitigation.

Abilities

  • Language: Read and write English with good comprehension, comprehend instructions, understand short correspondence.  Clearly write correspondence.  Effectively present information in one-on-one and small group situations to other employees of the organization.
  • Math: College level algebra is beneficial.  Ability to add, subtract, multiply, and divide, in all units of measure and in basic mathematical formulas, using whole numbers, common fractions and decimals.
  • Reasoning: Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.  Deal with problems and/or situations involving several variables.
  • Computer Skills: Intermediate level skills for clerical and administrative procedures and systems such as computer functions, word processing, spreadsheets, e-mail, internet, managing electronic and hardcopy files and other basic tasks.
  • Certificates and Licenses: Professional Certification in a discipline such as: Pneumatics / Hydraulics, Electrical Systems, PLCs Robotics, Control Systems, or other electro-mechanical disciplines is beneficial.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job the employee is regularly required to walk; use hands to finger, handle or feel; reach with hands and arms and stoop, kneel, crouch or crawl.  The employee is frequently required to stand; climb or balance and talk or hear.  The employee is regularly required to lift up to 10 pounds.  The employee is at times required to lift to 40 pounds.  The vision requirements include close vision, distance vision, peripheral vision, and depth perception.  (Note: distance vision, peripheral vision and depth perception are requirements for PIV Operators only.)

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job the employee is frequently exposed to dust airborne particles.  The employee is occasionally exposed to moving mechanical parts and high places.  The noise level in this environment is moderate.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Software Quality Engineer

Summary:

Cirtec Medical is searching for a Senior Software Quality Engineer to join its Quality team in the fast-paced medical contract manufacturing space.  This position is primarily responsible for monitoring and guiding during each phase of the development process ensuring the design and software adhere to both Cirtec’s Class III medical device quality standards and customer product specifications.

A successful Senior Software Quality Engineer helps meet deadlines by breaking up the software development process into attainable testing goals and relaying any issues back to the development and product teams.  They document processes and could implement creative ideas or solutions to improve the product.

Responsibilities:

  • Lead and perform software/firmware risk management activities
  • Refine/develop software development SOPs
  • Troubleshoot processes when defects occur.  Help to determine root cause and implement effective containment and countermeasures
  • Research and analyze product features being tested
  • Creation and review of software/firmware testing protocols
  • Help product development with achieving the manufacturing launch of new products including evaluating yield targets, run rates, training needs and quality results
  • Disposition non-conforming products and develop development re-work procedures where applicable.
  • Develop, test, and provide ROI cost justification for various tools or equipment recommended for manufacturing testing
  • Provide assistance and guidance to customers regarding external validation testing of product software
  • Drive innovation and streamline overall software testing processes
  • Provide guidance and mentorship to fellow engineers to improve software/firmware knowledge
  • Research new tools, technologies, and testing processes
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree in software design, engineering, computer science, or related field required
  • A minimum of 5 years of Software Quality Engineering experience in a Medical manufacturing environment.
  • Expert knowledge of IEC 62304 Software Lifecycle and Risk Management
  • Knowledge of scripting language (such as Python) a plus
  • Excellent verbal and written communication skills
  • Fluency in English
  • Thorough understanding of QA testing environments and software development life cycles
  • Previous experience with the ability to direct, lead and mentor engineers with respect to company engineering procedures, new product introduction, manufacturing support and tooling
  • Previous experience with Class III Medical devices, FDA standards, ISO 13485 and GMP principles preferred
  • Ability to lead, train, and engage manufacturing team members to reach Cirtec’s quality standards
  • The capacity to work well under pressure, change priorities on the fly, and take on new challenges
  • Project management skills and proven ability to work to tight deadlines
  • Teamwork and possess people management skills
  • A practical and logical approach to problem solving using lean six sigma concepts
  • Willingness to travel if required (<5%)

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT

Work is performed in an office/manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Calibration Technician

Summary:

This position will be responsible for ensuring Cirtec Medical inspection and testing equipment meets all defined and specified requirements related to their mechanical, electrical, and/or electronic performance, maintenance and calibration to ensure measurement/testing accuracy as applied to the determination of conformity for Quality Assurance and Control of Cirtec Medical products.

Responsibilities:

  • The position will be responsible for ensuring operational adherence and compliance to Cirtec Medical’s Quality Management System (QMS) requirements.   Specific elements of the QMS, as part of daily essential duties and responsibilities, include:
    • Inspection/Test Equipment Calibration & Maintenance,
    • Inspection/Test Equipment Selection and Qualification (Metrology and Gage R&R),
    • Inspection/Test Equipment Identification and Control.
    • Maintenance of the Calibration System to ensure that all inspection, measurement and test equipment, including mechanical, automated, of electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing accurate and valid results.
  • Additional duties and responsibilities include, but are not limited to:
    • Present equipment calibration and maintenance data to internal and external partners/customers.
    • Utilize knowledge of Statistical methods and tools to monitor and report on calibration system status and compliance.
    • Perform periodic audits of the calibration and maintenance systems to ensure compliance, control and accurate reporting of inspection/test equipment.
    • Support site internal and customer-requested auditing activities (Cirtec, Customer and Customer Regulatory Agencies).
    • Support and reinforce Quality Best Practices and GDP/GMP behaviors and continuous improvement efforts within Cirtec Medical.
    • Ensure all personnel are knowledgeable of, and adhere to, the Cirtec Medical Quality Management System and its requirements.
    • Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidelines and rules.
    • Must maintain an organized and operationally effective work environment.
    • Must adhere to professional workplace attire, time, attendance and leave of absence policies.
    • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

Required Education & Experience: 

  • High School Diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
  • 1-5 years of Manufacturing Quality experience.

Preferred Qualifications & Experience:

  • Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred).
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Other regulated manufacturing industry experience (e.g. Aerospace, Automotive, Defense, Pharmaceutical, etc.)
  • Knowledge of, and experience with, GMP/ISO Standards.

Technical Requirements, Skills and Training:

  • Strong verbal and written English language communication skills.
  • Must demonstrate ability to perform visual inspections (i.e. detect defects) using a microscope and/or magnification visual inspection system.
  • Must demonstrate ability to read manufacturing prints and identify associated specification/characteristics related to inspection and testing to be performed.
  • Must have a fundamental understanding of Quality Management Systems and how Calibration Systems fit in the overall scheme of Manufacturing Quality Control and compliance.
  • Must have a fundamental understanding of Quality philosophies, principles, systems, tools, standards and controls, internal customer service, and professional ethics.
  • Must be able to successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements as provided.
  • Must demonstrate ability and/or experience in computer use and general office software – Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT
Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Quality Receiving Inspector

Summary:

In the fast-paced medical contract manufacturing space, this position is primarily responsible for ensuring incoming products and materials meet all defined specifications.  Also, our Receiving Inspectors assist with day to day inspection of Cirtec Medical products for determination of conformity to the requirements.

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
  • Indicate inspection status of parts with assigned labels and stamps.
  • Maintain product identification and traceability.
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Protect product during handling and storage in the performance of work.
  • Monitor factory environmental conditions, record data and alert adverse conditions.
  • Assist with distribution and control of process documentation and quality records.
  • Assist with control of measuring and test equipment calibration.
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
  • Assist with statistical methods of verifying and controlling process capability.
  • Provide input when required to quality planning for specific projects and products.
  • Provide leadership to production personnel on quality issues.
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification and experience.
  • Provide Quality Support for the disposition of discrepant material.
  • Provide leadership to production personnel in relation to quality.
  • Provide Quality Control support to Manufacturing & Engineering.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Requires a high school diploma, GED, or equivalent
  • Requires directly transferrable work experience (experience in the engineering / manufacturing environment of medical device component assembly preferred)
  • 1-3 years of professional workplace experience
  • Prefer experience and familiarity with operations such as cleanroom manufacturing, swiss machining, milling, stamping, laser cutting, laser welding, coiling, crimping, swaging, adhesive bonding/backfill, liquid silicone & thermoplastic injection molding, annealing, and general mechanical assembly
  • Excellent working knowledge of technical drawings, blueprints, specifications, illustrations and geometric tolerances
  • Strong problem solving and process validation experience is a plus
  • Strong computer skills including MS Office, Project, Document Control systems, Adobe Acrobat
  • Must be able to read, write and speak fluent English
  • Possess good reading, writing, communication, and organizational skills
  • Maintain performance with changing priorities under minimal supervision
  • Possess strong team collaboration skills
  • Strong desire to learn and apply new technology
  • The employee may be required to work overtime and/or flexible hours, including weekends, nights and holidays based on special projects and/or critical situational business priorities.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.   The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 50 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT:

Work is performed in an office, cleanroom and/or manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Control Inspector – Third Shift

Summary:

This position is primarily responsible for performing receiving, first piece, in-process and final inspection or test on a wide variety of parts and document results. Indicate inspection status, maintain product traceability and non-conforming material control. Participate in internal audits, statistical process control and assist control of process documentation, records and equipment calibration.

This position will be on third shift Sun-Thurs 11pm-7:30am

Responsibilities:

  • Inspect, measure and/or test incoming parts, production first piece, in-process and final product, record results and notify appropriate personnel.
  • Indicate inspection status of parts with assigned labels and stamps.
  • Maintain product identification and traceability.
  • Control non-conforming product in accordance with documented procedures and verify timely corrective and preventative action.
  • Protect product during handling and storage in the performance of work.
  • Monitor factory environmental conditions, record data and alert adverse conditions.
  • Assist with distribution and control of process documentation and quality records.
  • Assist with control of measuring and test equipment calibration.
  • Participate in internal quality audits to verify compliance with documented procedures and specifications, record results and verify audit corrective action.
  • Assist with statistical methods of verifying and controlling process capability.
  • Provide input when required to quality planning for specific projects and products.
  • Provide leadership to production personnel on quality issues.
  • Comply with and reinforce the requirements of the Cirtec Quality System Manual and Standard Operating Procedures, ISO 9002, FDA Quality System Regulations and other customer standards.
  • Follow Occupational Safety and Health regulations, including laser safety practices.
  • Other agreed duties within the Quality Department consistent with training, qualification and experience.
  • Provide Quality Support for the disposition of discrepant material.
  • Provide leadership to production personnel in relation to quality.
  • Provide Quality Control support to Manufacturing & Engineering.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English
  • High school diploma
  • 3-5 years’ minimum experience in manufacturing, preferably medical devices, with increasing responsibility or a minimum of 5 years’ experience in a manufacturing environment.
  • Certificate/s of training related to this field of work (medical or quality assurance
  • 3 years’ experience as a Quality Control Inspector
  • Proven experience in inspection and documenting results
  • Able to demonstrate competence in interpreting technical drawings & specifications
  • Proficient in the use of microscopes, measuring and test equipment
  • Able to check dimensions, squareness, hole locations, surface relationships, finish material defects and mechanical strength of product following appropriate training
  • Have experience in the use of PC’s and Microsoft Office software applications

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

WORKING ENVIRONMENT:

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manager Assembly Engineering

Summary:

This position is primarily responsible to provide functional supervision to the manufacturing engineering department. The ME Manager will assist production technicians and project engineers in defining and developing processes prior to introduction into standard production and lead process improvement efforts and day-to-day support of production products. Managing new assembly products and contract review as these projects transition into operations.

Responsibilities:

  • Provide support & supervision to direct reports for the timely completion of projects, initiatives and key activities.
  • Mentor associates and foster a learning and growth environment. Perform evaluations at regular intervals.
  • Provides in-put for the budget process.
  • Organize a project plans with required actions.
  • Track and communicate project status, plans, issues, timelines, and action items.
  • Performs tasks to support the project engineers with the development of processes and documentation for new or modified products.
  • Works with technicians on developing processes and documentation for new or modified products.
  • Develops and implements process improvements for current production products.
  • Troubleshoot production processes when part failures occur.
  • Track key programs and report out overall performance.
  • Create action plans that will drive improvement.
  • Coordinate and direct projects, making detailed plans to accomplish goals and directing the integration of technical activities.
  • Communicate with customers on process improvements and/or manufacturing changes.
  • Participates in the development of new products, work with customers to understand their requirements.
  • Lead small projects, including standard work.
  • Prepare periodic reports on project activities.
  • Assign tasks to engineers.
  • Provide support for contract review of new components.
  • Collaborate with the sales team to create new products.
  • Perform other responsibilities duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Incredible problem-solving abilities.
  • Interpersonal skills to manage a team on engineers.
  • Ability to meet deadlines and manage projects.
  • Ability to handle multiple projects at any given time.
  • Above average oral and written communication skills at all levels for technical personnel and customer contact.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Willingness to travel, if required.
  • High ethical standards, good organizational skills
  • Demonstrated skills with project management tools, methodologies and problem solving.
  • Demonstrated success in leading and managing people in a team-based environment.
  • Must be able to read, write and speak fluent English.
  • Minimum Associates degree or equivalent experience. Preferred bachelor’s degree in an engineering discipline or equivalent.
  • Minimum 3 years of experience in manufacturing engineering.
  • Strong computer skills, including the MS Office suite.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Above average oral and written communication skills at all levels for technical personnel and client contact.
  • Ability to work independently using available resources.
  • Must have demonstrated organizational skills to manage multiple priorities and schedule revisions.
  • Must be able to use lean methodologies and drive a culture of change.

PHYSICAL DEMANDS:
While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT:
Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manager Component Engineering

Summary:

This position is primarily responsible to provide functional supervision to the manufacturing engineering department. The ME Manager will assist production technicians and project engineers in defining and developing processes prior to introduction into standard production and lead process improvement efforts and day-to-day support of production products. Managing new components and contract review as these projects transition into operations.

Responsibilities:

  • Provide support & supervision to direct reports for the timely completion of projects, initiatives and key activities.
  • Mentor associates and foster a learning and growth environment.  Perform evaluations at regular intervals.
  • Provides in-put for the budget process.
  • Organize a project plans with required actions.
  • Track and communicate project status, plans, issues, timelines, and action items.
  • Performs tasks to support the project engineers with the development of processes and documentation for new or modified products.
  • Works with technicians on developing processes and documentation for new or modified products.
  • Develops and implements process improvements for current production products.
  • Troubleshoot production processes when part failures occur.
  • Track key programs and report out overall performance.
  • Create action plans that will drive improvement.
  • Coordinate and direct projects, making detailed plans to accomplish goals and directing the integration of technical activities.
  • Communicate with customers on process improvements and/or manufacturing changes.
  • Participates in the development of new products, work with customers to understand their requirements.
  • Lead small projects, including standard work.
  • Prepare periodic reports on project activities.
  • Assign tasks to engineers.
  • Provide support for contract review of new components.
  • Collaborate with the sales team to create new products.
  • Perform other responsibilities duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Incredible problem-solving abilities.
  • Interpersonal skills to manage a team on engineers.
  • Ability to meet deadlines and manage projects.
  • Ability to handle multiple projects at any given time.
  • Above average oral and written communication skills at all levels for technical personnel and customer contact.
  • Operate effectively and maintain professionalism in an environment of deadlines and high workloads and adjust schedule or work hours to meet changes in priorities.
  • Willingness to travel, if required.
  • High ethical standards, good organizational skills.
  • Demonstrated skills with project management tools, methodologies and problem solving.
  • Demonstrated success in leading and managing people in a team-based environment.
  • Must be able to read, write and speak fluent English.
  • Minimum Associates degree or equivalent experience.  Preferred bachelor’s degree in an engineering discipline or equivalent.
  • Minimum 3 years of experience in manufacturing engineering.
  • Strong computer skills, including the MS Office suite.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Above average oral and written communication skills at all levels for technical personnel and client contact.
  • Ability to work independently using available resources.
  • Must have demonstrated organizational skills to manage multiple priorities and schedule revisions.
  • Must be able to use lean methodologies and drive a culture of change.

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

Work Environment:

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Manager, Development Quality

Responsibilities:

  • Manage the validation and design quality engineering team to provide strategic direction for Quality Assurance of Medical Devices.
  • This role works closely with hardware and software development teams to ensure quality compliant products.
  • Works with process development teams to ensure robust validation activities occur in a timely manner.
  • Oversee the review and approval of validation packages and design control related documentation generated on site such that the Quality Records comply with site and regulatory requirements.
  • Establish service level agreements to ensure timely completion and monitor teams performance in support of the sites validation, design control and on market change projects to ensure best speed to market for new/changed products.
  • Participate in the progress of failure/quality investigations and CAPAs associated with site validation and design control activities.
  • Implement and maintain site change, validation and design control activities through management of the Validation & Design Control QA group and interaction with the groups that execute such tasks.
  • Ensure that members of the department stay current on the requirements, practices, and training of the validation and design control regulations and guidance documents.
  • Ensure the expertise and material is available to be able to deploy change, validation and design control training to the site.
  • Work with Quality peers to ensure the development of consistent, best practice validation and design control policies and procedures.
  • Manage the Validation & Design QA budget to ensure spending is within agreed limits.
  • Maintain awareness of financial performance.
  • Support the development of cost-efficient business processes whilst ensuring compliance and quality requirements are met.
  • Take responsibility for financial planning of Validation & Design QA for future budget cycles.
  • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Requirements:

  • Minimum 4-Year degree or equivalent of directly transferrable work experience (Engineering discipline preferred).
  • Quality and/or Regulatory certification(s) preferred (ASQ, RAPS, etc.).
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDR, TGA, MHW, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPA and customer complaints.
  • Experience in effectively managing audits by customers and regulatory agencies.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
  • Experience with the preparation, review and catalogue of SOPs, Work Instructions and other Quality Systems documents.
  • Strong verbal and written communication skills. Ability to present complex data to internal and external contacts.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.
  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines, while increasing employee engagement and retention.
  • Experience with the preparation of Engineering protocols & reports.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Chandler, AZ

There are no positions open at this time. Please check back.

Opportunities in Enfield, CT

Quality Engineer-Design & Development

Summary:

The Design & Development Quality Engineer is responsible for providing support to product development teams and sustaining manufacturing/operations teams.  This individual will be expected to apply design control principles and techniques for medical devices. As a member of one or more cross-functional teams, this individual will ensure products are designed and developed in accordance with applicable regulatory requirements, customer requirements, and company policy.

Responsibilities:

  • Perform Design Quality Engineering activities throughout the design, development and production of medical devices to ensure compliance to company’s Design Control procedures and regulatory requirements (specifically FDA 21 CFR 820 and ISO 13485).
  • Create, review and/or approve technical Design Control documentation to facilitate design, development, and product verification testing of medical devices in collaboration with cross-functional engineering teams.
  • Create and execute Quality Plans for Product Design and Development projects.
  • Represent Quality Engineering in technical design and phase end reviews.
  • Develop and perform Design of Experiments (DOE).
  • Develop and validate test methods.
  • Develop sampling plans and acceptance criteria for product testing and inspection methods using appropriate statistical techniques.
  • Lead and/or participate in risk management activities, develop Risk Management Plans and Reports, perform Hazards Analysis and FMEAs (Failure Mode Effects Analysis) to evaluate and ensure product safety and functionality.
  • Conduct and/or support root cause investigations, develop and implement corrective and preventative actions for quality system and product related nonconformances.
  • Support quality system improvement initiatives and CAPA’s.
  • Responsible for the assessment of technical standards, labeling and technical file requirements.
  • Responsible for the assessment of component and system level specifications relative to customer needs and product performance specifications.
  • Perform requirement flow down analysis on critical to quality product performance specifications down to components and process.
  • Apply Design for Reliability and Manufacturability tools and techniques.
  • Support for multiple projects, balancing priorities and resources to meet both project and management expectations.
  • Prepare reports required by the project or department management.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • B.S. Degree in Engineering or associated fields, or equivalent industry experience.
  • 2+ years’ experience in design, quality, or reliability engineering in medical devices.
  • Knowledge of quality assurance and regulatory compliance including Quality System Standards and Regulations.
  • Knowledge of product development processes and methods.
  • Knowledge of systems engineering discipline, Technical Standards, Hazard Analysis and Failure Mode and Effects Analysis (FMEA), Qualification, Test Method and Process Validation.
  • Knowledge in the application of risk management.
  • ASQ Certification preferred.

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

2nd SHIFT-Technician I

Summary:

This position is primarily responsible for manufacturing processing, inspection, standard documentation and packaging of products. The Technician I works under the direction of the Production Team Leader and the upper level Technicians they are assigned to assist or be trained by.  This position is designed to augment the ability of the Technician’s and other manufacturing personnel to meet goals for quality and production rates in a cost-effective manner.

Responsibilities:

  • Primary function of assisting production operators and technicians engaged in processing and product fabrication.
  • Will be proficient in the task of loading components into product specific tools.
  • Demonstrates strict adherence to all safety, GMP & quality system guidelines.
  • Has the responsibility of following established documentation for product manufacturing.
  • Must accurately document all work performed on inspection reports and customer travelers.
  • Performs in-process visual inspections with and without the use of microscopes in accordance with the requirements stated in the Process Control Document or as otherwise stated on drawings or work instructions.
  • Performs pre-weld operations such as assembly and part cleaning.
  • Performs various post-weld operations such as cleaning or post weld assembly.
  • Assists in packaging of finished goods as needed.
  • Maintains cleanliness of work areas, machines, tools and equipment.
  • Assists Quality Control with inspection duties as required.
  • Performs other duties as assigned by the Production Manager.
  • Takes direction within the manufacturing cell from upper level Technicians assigned to that cell.
  • Performs workstation set-ups with assistance from qualified technicians.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Must be able to read, write and speak fluent English.
  • High school diploma or General Education Degree (GED) is required.
  • Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

NPI Buyer

Summary:

The New Program and Product Introduction Buyer is responsible for sourcing, selection and development of vendors in support of strategic projects and programs. The NPI Buyer will lead sourcing efforts during the design and development process of new and existing medical devices and device components. The role requires effective communication and collaboration with project and program teams as well as external partners and vendors. Strong multitasking skills required to ensure all program deliverables are completed successfully.

Responsibilities:

  • Responsible for vendor selection, qualification and development.
  • Quote and procure components, services and equipment required for assigned projects and programs.
  • Develop strong relationships with vendors to ensure quality and delivery at best in class costs.
  • Establish and improve purchasing and planning parameters (lead times, MOQ’s, tiers and pricing).
  • Ensure vendor performance supports design requirements and production goals.
  • Review MRP to verify accurate demands and to place orders for inventory components on a timely basis.
  • Transition production ready vendors, supplies, and services to sustaining buyers.
  • Support project and program teams as key sourcing and supply chain resource.
  • Work with Engineering to review new item masters to ensure compliance with finance, inventory and purchasing guidelines.
  • Execute other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Demonstrated supply chain creation, management, and improvement experience.
  • A record of creating and improving vendor relationships.
  • Demonstrated experience in technical sourcing resulting in improved quality, delivery, cost and inventory turnover.
  • Ability to read and interpret technical specifications, prints and requirements.
  • Experience in ASIC, PCBA, and related supply chains a plus.
  • Minimum of 5 years’ experience in contract and or medical device manufacturing with demonstrated progressive sourcing experience.
  • Bachelor’s degree preferred.
  • Working knowledge and experience in Lean and Six Sigma methods, ERP and QMS systems, and logistics and procurement processes.
  • Experience with ISO 9001 and ISO 13485 procedures preferred.
  • Execute other duties as assigned.

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Supply Chain Manager

Summary:

The Supply Chain Manager is responsible for management and execution of planning, purchasing, scheduling and materials management. The role drives continuous improvement in safety, reliability, cost, and team development. The role creates and leads teams while contributing directly to the success of multiple locations on site leadership teams. The Supply Chain Manager establishes and nurtures internal relationships to solve problems, drive improvement and successfully meet customer requirements. The role is responsible for ensuring business tool capabilities are leveraged fully. Strong team development and change management skills are required.

Responsibilities:

  • Serve on leadership teams to develop and execute business growth strategies
  • Develop and manage a multi-site, cross-discipline supply chain organization
  • Ensure smooth transfers to manufacturing during design transfer and insourcing efforts
  • Drive continuous improvement in supply planning and production scheduling
  • Provide change management leadership to formal and informal teams
  • Own on time delivery to Customers
  • Produce favorable total cost of ownership variances year over year
  • Drive improvement in cash flows through inventory velocity and customer- vendor- owned inventory programs
  • Establish and improve KPIs associated with supply chain functions such as schedule attainment, purchase price variance, inventory turns and accuracy, etc.
  • Improve supply planning accuracy — work with multiple departments to correct data used in ERP systems to effect step improvements targeting capacity utilization and constrained supply plans
  • Design and improve business processes to improve internal supply chain performance
  • Manage SIOP data including deployment of supply plans and development of capacity feedback models (RCCP)
  • Manage medium- and long-term improvement projects across functions and locations.
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Demonstrated supply chain management and improvement experience
  • Ability to solve problems and build consensus among teams
  • Strong leadership, communication, and change management skills
  • Experience leading and implementing SIOP/S&OP processes
  • A record of improving on time delivery through forecasting, supply planning, capacity planning, inventory, and production planning
  • Working knowledge and experience in Lean and Six Sigma methods
  • Experience implementing or improving ERP and QMS systems preferred
  • Logistics, procurement and warehouse management experience required
  • Experience operating in regulated industries – experience with ISO 9001 or ISO 13485.
  • Minimum of 5 years’ management experience in medical, pharmaceutical and or contract manufacturing
  • Bachelor’s degree, MBA preferred
  • Frequent travel between Enfield, CT and Lowell, MA

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.   The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Los Gatos, CA

Quality Manager

Summary:

This position is responsible for the leadership and management of all site Quality personnel and resources to ensure adherence and compliance to Cirtec Medical’s Quality Management System. The Site Quality Manager shall be the designated Site Quality Management Representative for the Quality Management System of their assigned Cirtec Medical site(s).  This position will be responsible for the Los Gatos, CA site and includes management of the Chandler, AZ site.

The Los Gatos, CA site has primary quality activities focused on design and development but includes GMP manufacturing.

Responsibilities:

  • Manage the Quality team to provide strategic direction for Quality Assurance of Medical Devices and acts as a key stakeholder in Design Reviews.
  • Ensure Design/Development programs are adequately supported for all levels of Design Control (Definition/Concept through Commercialization).
  • Review, and contribute to key Design Control and Risk Management deliverables on Development programs, such as Quality Plans, Risk Management Plans, Master Verification Plans, etc.
  • This role works closely with hardware and software development teams to ensure quality compliant products.
  • Works with process development teams to ensure robust validation activities occur in a timely manner.
  • Oversee the review and approval of Design and Process validation packages and design control related documentation generated on site such that the Quality Records comply with site and regulatory requirements.
  • Provide direction in characterizing and establishing effective and robust test/inspection methods.
  • Ensure Risk Management and Hazard Analyses strategies are established in cooperation with cross-functional engineering teams per project requirements.
  • Designated Site-level Management Representative for assurance of compliance to the Cirtec Medical Quality Management System and member of the Site-Senior Management Team for the facility.
  • Drive and support corporate QMS initiatives and continuous improvement activities.
  • Ensure establishment and maintenance of site regulatory registrations (ISO 13485, FDA, etc.)
  • Provide leadership and guidance for site-level Quality functions including inspection, CAPA, nonconformances, internal audit, purchasing controls, and product release support.
  • Provide Leadership and guidance for site-level sustained manufacturing and continuous improvement/continuation engineering activities and initiatives.
  • Oversee and coordinate site auditing activities (Customer and Customer Regulatory Agencies).
  • Support the development of cost-efficient business processes while ensuring compliance and quality requirements are met.
  • Other duties and responsibilities as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum 4-Year degree or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 4 years Leadership/Supervisory-level experience, with budget and decision-making authority/responsibilities.
  • Minimum of 6 years’ experience in a regulated manufacturing environment (e.g., Medical Devices, Pharmaceutical, etc.)
  • Quality certification(s) desired (e.g., ASQ CQE, QM/OE, SSBB, etc.)
  • Class II and/or III Medical Device manufacturing experience.
  • Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control, nonconforming materials, Corrective and Preventive Actions, and customer complaints.
  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
  • Experience in effectively managing audits by customers and regulatory agencies.
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
  • Strong verbal and written English language communication skills.
  • Competency with Microsoft Office (i.e., Outlook, Word, Excel, and PowerPoint).
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Ability to work with a variety of functional areas, including R&D, Manufacturing, and QA.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT:

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Principal Mechanical Engineer

Summary:

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

As a Principal Mechanical Engineer, you will lead a dedicated product development teams to bring complex mechanical designs from concept to market. You will be responsible for the development of long-term implants, delivery systems and external medical devices.

Responsibilities:

  • Lead product development of complex mechanical and electromechanical medical devices through various development phases
  • Lead creation of product requirements and design specifications, and determine applicable regulatory standards and ensures appropriate integration into product requirements
  • Generate and maintain computer-aided drawings (CAD) using Solidworks, schematics and component specifications to document mechanical designs
  • Drive hands-on fabrication and testing of prototypes using bench testing, animal and/or cadaver studies to evaluate product designs, and recommend and implement design modifications
  • Perform detailed design reviews and tolerance analyses to achieve product performance, cost, reliability and manufacturability requirements
  • Serve as the principal technical contact with customers and communicate directly with customers to understand project / product needs, and present technical updates, risks and issues
  • Effectively interface with and manage suppliers to fabricate prototype and final components
  • Develop test plans and protocols, and executes prototype testing and design verification testing
  • Lead and contribute towards creation of risk management documentation, including FMEAs
  • Create engineering-level manufacturing process instructions, bill of materials and related manufacturing documentation
  • Proactively anticipate technical risks and issues, and formulate and implement risk mitigations and corrective/preventive actions
  • Assist program managers in developing and maintaining project plans, and in tracking program health in terms of schedule, budget, and technical risks and issues
  • Collaborate with cross-functional team members to create and maintain Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements
  • Mentor and provide guidance to other engineers and technicians
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • BS in Mechanical / Biomedical Engineering with minimum 10-15 years’ experience within the Medical Device industry
  • Experience with development of structural heart implants and delivery systems highly preferred
  • Knowledge of materials and processes used in manufacture of catheters and development of Nitinol components highly preferred
  • Strong understanding of mechanical component manufacturing (i.e. injection molding, machining, sheet metal fabrication, etc.)
  • Proven experience and proficiency using Solidworks for mechanical design
  • Strong working knowledge and understanding of GD&T and mechanical design standards
  • Excellent communication skills, both written and oral

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT:

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Mechanical Engineer

Summary:

Cirtec Medical is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development, and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably, and cost-effectively.

As a Mechanical Engineer, you will work on product development teams to bring complex mechanical designs for implants, surgical devices and external electromechanical devices from concept to market.

Responsibilities:

  • Applies engineering knowledge and skills as technical engineer for all phases of development projects.
  • Generate and maintain computer-aided drawings (CAD) using Solidworks, schematics and component specifications to document mechanical designs.
  • Participates in hands-on fabrication and testing of prototypes using bench testing, animal and/or cadaver studies to evaluate product designs and recommend and implement design modifications.
  • Perform detailed design reviews and tolerance analyses to achieve product performance, cost, reliability, and manufacturability requirements.
  • Effectively interface with and manage suppliers to fabricate prototype and final components.
  • Develop test plans and protocols and executes prototype testing and design verification testing.
  • Creates medical device manufacturing process instructions, bill of materials, lot history travelers, and related documentation.
  • Contributes towards coordinating and scheduling other staff to work on specific tasks.
  • Communicates directly with clients to understand needs and present results.
  • Effectively interfaces with and manages suppliers to fabricate prototype and final design components.
  • Participates in product risk management and develops and implements risk mitigation strategies.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelors in Mechanical / Biomedical Engineering, or an equivalent engineering discipline
  • Minimum 1-3 years’ experience within the Medical Device industry
  • Experience in development of electromechanical devices (i.e. cable design, wire schematics, integrating PCBAs into mechanical assemblies, etc.) highly preferred
  • Experience with CAD design using SolidWorks
  • Excellent communication skills both written and oral
  • Experience and working knowledge of medical device design control processes highly preferred

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT:

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Design & Development Quality Engineer

Summary:

Essential responsibilities of the Design & Development Quality Engineer are activities associated with Design Control and Design Quality Assurance during the Product Design and Development Process of mechanical and electro-mechanical medical devices and medical electronic equipment.  Additional general duties and responsibilities include, but are not limited to: statistical qualitative and quantitative data analysis; returned product complaint investigation and analysis; quality engineering support to sustained low volume, high value manufacturing projects; manufacturing process validation; supplier quality; gage R&R; and other Quality Management Systems functions as this role is expected to provide input and contribute on Quality System improvement strategies and approach. The Design Quality Engineer position reports up to the Quality Manager or Site Quality Leader.

Responsibilities:

  • Provide Design Quality Engineering support throughout the design, development and production of mechanical and electro-mechanical medical devices and medical electronic equipment to ensure compliance to company’s Design Control procedures and regulatory (specifically FDA 21 CFR 820 and ISO 13485) standards.
  • Author, review and/or approve technical Design Control documentation to facilitate design, development and product verification testing of medical devices and medical electronic equipment in collaboration with cross-functional mechanical, electrical and software engineering teams.
  • Author and execute Quality Plans for Product Design and Development projects.
  • Represent Quality Engineering in technical design and phase end reviews.
  • Develop protocols and performing Design of Experiments (DOE) and Gage R&R for processes used in manufacturing and testing of medical devices and medical electronic equipment.
  • Develop inspection plans and providing quality engineering support for Incoming Inspections (including First Article Inspections), In-Process and Final Product Inspections.
  • Develop sampling plans and acceptance criteria for product testing and inspection methods using appropriate statistical techniques (e.g. AQL – Acceptable Quality Level) and software tools (e.g. Minitab).
  • Lead and/or Participate in risk management activities, and developing Risk Management Plans and Reports, performing Hazards Analysis and FMEAs (Failure Mode Effects Analysis) to evaluate and ensure product safety and functionality during development and production.
  • Conduct and/or support root cause investigations, develop and implement corrective and preventative actions for quality system and product related nonconformances.
  • Support sustained manufacturing for low volume, high value products.
  • Support quality system improvement initiatives and CAPAs.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor of Science in Engineering or related technical discipline with a minimum of 3 – 5 years of experience in Medical Device.
  • Experience with medical device design and manufacturing requirements, specifically in the areas of design control and design transfer to production.
  • Demonstrable knowledge of and/or working experience with Design Assurance tools and methodologies including: Design Controls, Design Change Assessment, Risk Management (Hazard Analysis), Design and Process FMEA, Statistical Analysis, Process Qualification, Gage R&R, and Test Method Validation.
  • Knowledge of and/or working experience with external standards and regulations: ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), especially pertaining to product development, design controls, good manufacturing practices, supplier qualification and management, quality control, CAPAs and customer complaints.
  • Strong verbal and written English language communication skills, including experience in technical protocol and report writing.
  • Ability to work in collaboration with cross-functional groups and teams including R&D, Manufacturing, Electrical Engineering, Software, and Quality Assurance to accomplish results with minimal guidance.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.
  • Training or equivalent work experience with general computer use and software applications (e.g. Microsoft Word, Excel, Power Point, Visio and Access).
  • Knowledge of and/or working experience with statistical software tools (i.e. Minitab) preferred.
  • Must be able to drive and implement quality initiatives, interpret collected data, and present the data to multiple levels of management as part of continuous improvement engineering activities.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT:

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Lowell, MA

Operations Controller

About Cirtec Medical:

Founded nearly three decades ago, Cirtec Medical has become one of the medical industry’s most innovative, cost-effective and comprehensive resources for developing and manufacturing Class II and Class III devices.

Its vision is to become an industry innovator by 1) building a network of the industry’s most confident and loyal customers, 2) inspiring its employees to be the best they can be, 3) cultivating a culture based on integrity and trust, and 4) generating consistent growth while maintaining quality in its products.

Today the company has manufacturing and engineering centers in Minnesota, California, Connecticut, Massachusetts, and Arizona, with operations in the Central America and Europe. In total, the team at Cirtec Medical is made up of over 800 full time employees.

Reporting Relationships

The Site Controller will assist the CFO and General Manager in improving overall operations of the manufacturing facility in Lowell, MA will report directly to the CFO and will be a business partner to the General Manager.

Job Summary

Cirtec Medical is seeking a talented, passionate and highly motivated Site Controller.

The Site Controller will be a strategic thought and business partner. The successful candidate will be a hands-on, participative manager. The Site Controller will participate in the development of a long-term operations strategy for the manufacturing plant and will drive execution of the key elements. He/she will create, monitor and drive the achievement of financial operational metrics across all functional areas. The Site Controller is a critical participant in all significant decisions within the functional area, facilitating strong analysis and problem solving, as required. The Site Controller is expected to drive execution of key business initiatives and outcomes.   It is expected that the Site Controller will drive process improvements through a variety of projects and initiatives that will result in superior financial performance.

The Site Controller should have these qualifications:

  • A seasoned financial and manufacturing operations professional with at least 5 years of related business experience and a progressive career path in an industrial manufacturing environment.
  • A proven ability to achieve results as a member of an operating leadership team working within a matrix environment.
  • Evidence of a penchant for doing whatever is needed to get things done well and on time.
  • The Candidate should be a high-potential leader with high level career ambitions and the ability to advance beyond the functional role.

Responsibilities:

  • Experience in a similar or tangential role in an organization of similar size, with an understanding of the issues associated with a specialized, diverse, technical business.
  • Thorough operational understanding of a manufacturing and sales company.
  • Experience with lean manufacturing and a history of partnering with operations leadership to drive key initiatives
  • Well-developed cost/managerial accounting skills, including standard cost and project cost accounting. Ability to overhaul existing standard cost system.
  • Strong experience driving key metrics, reporting, and “anticipating” key issues based on forecasts, manufacturing capacity, and partnering with the Operations leadership (Plant Manager) to mitigate risk.
  • Honed analytical and problem-solving skills. A strong propensity to action and problem solving through sound judgement, proactivity, and efficient organization.
  • Proven communication and interpersonal skills at all levels within the organization. Interest in being a Team-Player both with the Operations Team as well as the Company-wide Finance Team.
  • Ability to communicate analyses and performance metrics in a clear, simple and compelling manner. Strong influencer with a demonstrated successful track record for highlighting areas of opportunity and partnering with the General Manager on measurable action plans.
  • The ability to function and shift rapidly between both the strategic and tactical, bringing perspective to senior management while displaying a “hands-on” mentality with associates at all levels of the organization, especially in the manufacturing plant.
  • Strong commercial awareness and tenacious and persistent focus on delivery of value, profit and cash objectives.
  • The ability to lead change and work well within an organization that is rapidly growing and without mature systems and processes, can still innovative and driven results.
  • The ability to lead others in a matrix environment within Finance and Operations, including coaching and developing others.
  • Strong sensitivity to the voice of the customer, both internal and external. Customer focus will underscore all decisions.

Year One Critical Success Factors:

  • Develop robust processes and reporting with clarity around operational activity in the month that drove the financial results.
  • Own and drive improvements with the standard cost process including leading the effort on labor rates, routings, and material cost through the annual standard cost roll.
  • Works well with Finance peers at other sites to share best practices and help drive change, process improvements, and nimbleness.
  • Enhance and/or develop reporting metrics and tools for the daily, weekly, monthly, and quarterly reporting of plant performance. Drive delivery of the financial commitments made by the Operations team.
  • Ensure delivery of savings targets related to the company’s key capital investments.
  • Ensure that new capital investments and sourcing decisions are supported with sound financial analyses.
  • Develop tools that can be leveraged going forward for future projects.
  • Support centralization efforts of routine accounting duties to Corporate to free up time which will allow for more analysis and operational analysis that drive good business results.

Personal Characteristics:

The Site Controller will be characterized by the following traits:

  • Humility: Is comfortable in own skin and wants credit to go to others for business achievements. Not afraid to ask for help and seek guidance when needed. Receives criticism with grace and is willing to change direction when presented with a better solution. Practices servant leadership.
  • Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
  • Drive for Results: Is action oriented and focused on producing good outcomes. Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others forward to the goal.
  • Builds Effective Teams: Blends people into teams and inspires them to perform; creates strong morale and spirit in his/her team; shares wins and successes with functional and operating peers as well direct reports; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates a feeling of belonging in the team.
  • Improvement Agility: An improvement leader; creates effective plans to promote improvements; knows how to manage in changing circumstances; strongly advocates an independent point of view but can be counted on to execute management decisions and strategies; understands the need for improvements before being told; seizes opportunities.
  • Intellectual Horsepower: Able to grasp complex issues and understand the essence of the challenges at hand. Assimilates new information quickly and does not get overwhelmed when needing to move quickly from one topic to another.
  • Problem Solver: Steps up to conflicts, seeing them as opportunities; reads situations quickly; good at focused listening; can hammer out tough agreements and settle disputes equitably; can find common ground and get cooperation with minimum noise. Deals fairly with non-performance and is unafraid to deliver tough messages when necessary.   Has the ability to not only identify problems but is proactive is identifying and implementing the solution.
  • Champions Integrity and Trust: Is widely trusted; is seen as a direct, truthful individual; can present the unvarnished truth in an appropriate and helpful manner; keeps confidences; admits mistakes; does not misrepresent him/herself for personal gain.

Qualifications:

The Site Controller will be a strategic, yet hands-on business leader, capable of working with the leadership team to develop a strategic plan, setting goals and objectives, and leading a team in the execution of the plan.

Additionally, candidates for this role will:

  • Have strong educational credentials, an understanding and history of driving manufacturing excellence, and a demonstrated commitment to life-long learning and development.
  • Have a successful track record as an all-in financial leader and manager.
  • Have five or more years of financial leadership experience in a Manufacturing environment.
  • Understand how to apply Operational Excellence and Lean tools to manage a business more effectively.
  • Be capable of “telescoping” – balancing the strategic and hands-on tasks needed to successfully lead a team.
  • Be known for exceptional personal interaction with customers.
  • Possess strong communication skills and a personable, engaging management style.
  • Have provided documented business and organizational change leadership and, ideally, have been successful doing so in more than one company.
  • Have an in-depth understanding of managerial cost accounting and the related reporting required
  • Have proven skills in mentoring a team within manufacturing organizations and emphasizing people development throughout an organization.
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Technician

Summary:

This position is primarily responsible for the manufacturing and assembly of sterile and non-sterile medical devices.

Responsibilities:

  • Comply with all Good Manufacturing Practices (CGMP) requirements to ensure products are consistently produced and controlled according to the Quality System.
  • Ensure that all Manufacturing Instructions / Inspection Instructions are followed when building client products.
  • Maintain an orderly and clean production line at all times while building products.
  • Reads specification drawings and process documents.
  • Operates a variety of wafer fab equipment in a production environment.
  • Able to manually manipulate fragile wafers on a regular basis.
  • Able to work with microscopes and vision systems for extended amounts of time.
  • Works with small devices to load fixtures and process equipment.
  • Makes basic measurements and math calculations relative to tolerances, dimensions.
  • As instructed, adjusts machines to achieve conformance with specifications and maximum yield.
  • Utilizes multiple software systems to document and execute transactions.
  • Ensures adherence to clean room protocol and follows all safety requirements/regulations.
  • Comply with company safety policies and procedures.
  • Maintain multiple machines throughout the cleanroom.
  • May be responsible or assigned to final inspection as needed.
  • Performs related duties as directed by Production Supervisor and/or Management.

Qualifications:

  • High School Diploma.
  • Must be able to read, write and speak fluent English.
  • Strong attention to detail.
  • Knowledge of ISO & FDA requirements a plus.
  • Experience with LEAN manufacturing a plus.
  • Ability to work in environment subject to fluctuations in heat, humidity, fumes, odors, dust, and noise.
  • Ability to provide detailed information to assist sustaining engineering in determining root cause in order to identify the appropriate corrective action.
  • Good interpersonal skills.
  • Good written and verbal communication skills.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee may be required to sit, stand, and/or walk for 10 hours at a time. The employee must occasionally lift and/or move up to 20 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: PPE

WORKING ENVIRONMENT:

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Manufacturing Engineer

Summary:

This position is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications and Class III medical device quality standards.  This position recommends and implements improvements to sustained production processes, methods and controls; as well as coordinates the launch of new products into pilot/sustained production. This position also administers standard processes and programs to ensure effective, timely and accurate standards and customer satisfaction.

Responsibilities:

  • Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
  • Prepares engineering change orders and coordinates the deployment of changes including training operation team members.
  • Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
  • Coordinates the manufacturing launch of new products including establishing yield targets, run rates, training needs and evaluating results.
  • Develop, test and cost justify various tools and equipment recommended for manufacturing methods.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
  • Utilizes tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks and the associated corrective actions.
  • Supporting required equipment qualification/process validation.
  • Troubleshoot processes when defects occur. Determine root cause and implement effective containment and countermeasures.
  • Disposition non-conforming products and develop re-work procedures.
  • Communicate with customers regarding process improvements and production changes.
  • Represent manufacturing on cross functional teams.
  • Participate in Kaizens and drive improvement efforts.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Bachelor’s degree in Engineering or related field required.
  • Advanced knowledge of manufacturing and assembly processes.
  • A minimum of 5-8 years of engineering experience in a Medical manufacturing environment.
  • Previous experience and the ability to direct, lead and mentor engineers with respect to company engineering procedures, new product introduction, manufacturing support and tooling.
  • Excellent verbal and written communication skills.
  • Fluency in English.
  • Previous experience with Class III Medical devices, FDA standards, ISO 13485 and GMP principles preferred.
  • Ability to lead, train, and engage manufacturing team members to reach Cirtec’s quality standards.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Association with supporting documents including, ECN’s, process deviation, non-conformances, stop shipment notifications and all associated quality related documents.
  • Strong computer skills associated with MS Office suite, Minitab and SolidWorks a plus.
  • Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
  • The ability to understand a range of engineering functions and procedures.
  • A practical and logical approach to problem solving using lean six sigma concepts.
  • Interpersonal, presentation and communication skills.
  • Team working and people management skills, along with organizational and time management skills
  • The capacity to work well under pressure and take on new challenges.
  • Project management skills and the ability to work to tight deadlines.
  • Willingness to travel, if required.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None/PPE

WORKING ENVIRONMENT:

Work is performed in an office/manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Supervisor Production - Weekend 1st Shift

Summary:

This position is primarily responsible to direct the development and implementation of activities in production area(s) to meet production goals, quality, and cost objectives. Plan, organize and schedule production activities to meet customer demands. Provide direction, leadership and motivation to production personnel, including training and assistance with adhering to the quality system.

Responsibilities:

  • Provide leadership and direction across the associated shift ensuring proper levels of production and quality are met.
  • Responsible for ensuring conformance to all company policies, procedures and work instructions.
  • Plan, organize, and schedule production activities (including personnel and equipment) to meet schedules for both standard production and development projects.
  • Maintain production goals and deadlines. Preemptively coordinate material and system requirements to ensure minimum amount of downtime and recommend measures to improve production methods, yields, and the quality of product.
  • Manage production personnel, including planning personnel needs, participating in the hiring process, and managing performance.
  • Conduct daily team meetings for proper communication and development of production team.
  • Develop in depth knowledge of production processes and associated equipment, including laser workstations and CNC motion control programs.  Troubleshoot manufacturing issues as part of maintaining production schedule and developing self-reliance among production technicians.
  • Contribute to development, maintenance, and follow up of production metrics.
  • Plan, implement, and maintain the production environment with focus on safety, cleanliness, and organization.
  • Participate on and lead teams that improve safety, quality, and reliability in the production area, as well as teams that support cost saving and team building initiatives (QDC).
  • Plan and implement technical skills training for production personnel, including generic and product specific skills. Act as trainer when necessary.
  • Understand the requirements of and ensure compliance with the preventative maintenance program.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English
  • Associates degree or equivalent experience in a related field
  • Computer literate (MS Office Suite, Syteline)
  • Understanding and implementation of Lean Manufacturing and Six Sigma for process improvement and problem solving.
  • Strong knowledge of ERP/MRP business functions.
  • Able to prioritize and manage multiple responsibilities.
  • Must be able to read blue prints and interpret technical specifications and illustrations.
  • Experience in technical report writing and verbal communication skills.
  • Minimum 3+ year’s supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT:

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Equipment Maintenance Technician

Summary:

This position is primarily responsible for all preventative and corrective maintenance on equipment located in the fab and plating areas.  Maximum emphasis is placed on positive response to the concerns and needs of the company and its environmental health and safety. This is a hands-on position that the equipment maintenance technician works independently and is capable of being successful in a matrix organization.

Responsibilities:

  • Responsible for preventative and corrective maintenance on all fab / plating area tool sets, including component disassembly / assembly / repair
  • Responsible for identifying needed parts for repairs / preventative maintenance
  • Properly hand and store chemicals and hazardous waste
  • Maintain written logs of maintenance and repairs in our online system
  • Ensure that facility maintenance requirements are consistently met
  • Promptly respond to facilities related issues and ensure effective resolution
  • Keep apprised of current regulations in order to effectively address and ensure compliance with ADA (Americans with Disabilities Act), OSHA (Occupational Safety & Health Administration), fire codes requirements, and Material Management for Hazardous Material
  • Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Minimum 4 years’ experience in performing preventative and corrective maintenance on semiconductor related equipment.  Similar equipment experience will be considered.
  • Able to troubleshoot electronic circuits to a component level.
  • Familiar with vacuum systems.
  • Must have good computer, written and oral skills.
  • Manual dexterity and visual acuity are required to perform responsibilities.
  • Must be able to lift 60 lbs.
  • Must be willing to work some weekends, alternating coverage with other maintenance techs.
  • Must be legally authorized to work in the United States.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 60 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None/PPE

WORKING ENVIRONMENT:

Work is performed in both an office and manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Circuit Design Engineer

Summary:

This position is primarily responsible for working in a functional engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients (internal and external).
  • Assist with preparation of proposals and quotations. May be required to interface with clients to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets
  • Designs flex circuits, rigid flex, and PCB circuits using customer supplied data, schematics, Gerber files, and component specifications.
  • Creates 2D and 3D CAD models of circuitry using SolidWorks, Altium, and other applicable software
  • Manipulates electronic data files using Gerber, OB++, various CAD packages, and 3D modeling such as AutoCAD and SolidWorks
  • Establishes electrical functionality (current, Isolation, and stack up requirements)
  • Specifies components, solder, underfill, and cover lay materials use on circuit assemblies
  • Define and review test requirements to verify circuit performance
  • Designs and specifies test fixtures in support of circuit performance verification
  • Specifies metal schemes, base materials and other features as related to circuit performance
  • Troubleshoots existing designs in support of sustaining manufacturing
  • Defines and maintains electronic library in support of company’s standard offerings
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • Able to follow cleanroom and ESD policies, become familiar with and practice 6S principles in order to maintain a safe, neat, and orderly workplace.
  • Willingness to travel, if required.
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in Electrical Engineering and minimum 4-years appropriate work experience; or Associates degree in Electrical Engineering and a minimum or 6-years appropriate work experience; or a minimum 10-years relevant work experience; or equivalent.
  • Must have working knowledge in analog and digital circuit and system design
  • Experience with electrical and mechanical interfaces (connectors, mechanical aspect of PCBs, flex circuits, wire-harnesses, fuses, indicators etc.)
  • Must have working knowledge of in electronics engineering principles and methods is a must; knowledge of design standards IPC-2220 series and acceptability for electronic assemblies per IPC-A-610C
  • Must have a working knowledge of printed circuit board CAD data and assembly equipment programming software, and databases.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
  • Ability to learn and apply new technology.
  • Technical report preparation and formal presentation skills.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: Standard PPE and cleanroom garments

WORKING ENVIRONMENT:

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

SMT Engineer

Summary:

This position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients (internal and external).
  • Assist with preparation of proposals and quotations. May be required to interface with clients to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
  • Develop process and capacity utilization strategies for SMT assembly operations.
  • Develop paste printing, automated paste inspection, component pick and place, reflow profile, and inspection processes.
  • Assists is the selection of SMT/SMD equipment.
  • Operates SMT equipment in support on production and process development.
  • Identify the root cause of quality issues and develop corrective action plans to improve.
  • Ensure the production readiness of SMT processes within the PCBA cycle.
  • Design optimum production processes such as solder paste selection, reflow profiles, stencil designs, component feeder set up methodology, and selective soldering techniques.
  • Optimize equipment set up and programming sequences.
  • Write DFM reports in support of customer proposals.
  • Manipulates electronic data files using Gerber, OB++, various CAD packages, and 3D modeling such as AutoCAD and Solidworks.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  •  Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • Able to follow clean room and ESD policies, become familiar with and practice 6S principles in order to maintain a safe, neat, and orderly workplace.
  • Willingness to travel, if required.
  • Must maintain high ethical standards.
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in an engineering discipline and minimum 4 years appropriate work experience; or Associates degree in engineering discipline and a minimum or 6 years appropriate work experience; or a minimum of 10 years relevant work experience; or equivalent.
  • Must have extensive knowledge with surface mount and through-hole technologies.
  • Must be familiar with IPC/EIA J-STD-001 and IPC-A-610.
  • Must have working knowledge of all SMT assembly and inspection processes.
  • Must have a working knowledge of printed circuit board CAD data and assembly equipment programming software, and databases.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
  • Ability to learn and apply new technology.
  • Technical report preparation and formal presentation skills.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: Standard PPE and cleanroom garments

WORKING ENVIRONMENT:

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Control Technician

Summary:

This position is primarily responsible for supporting manufacturing, is responsible for ensuring that all products produced at the site meet or exceed customer requirements, specifications and expectations for Quality. This is accomplished through consistent monitoring, oversight of execution, and coaching activities for the following production operations:  Incoming inspection of materials; packaging; In-process and post-process inspection of WIP materials; acceptance for Inventory; and shipment from Finished Goods.  The Quality Control group utilizes systemic controls and support systems for this purpose to include, but not limited to: Measurement Equipment Calibration & Control; Materials Identification & Traceability; Internal Auditing; Corrective and Preventive Actions; and Control of Nonconforming Materials.

Responsibilities:

  • Ensure Operational compliance to Quality Management Systems Processes/Procedures and Manufacturing Process Instructions.
  • Provide independent oversight of the Production floor / Controlled Environment rooms to ensure high product quality and good documentation practices.
  • Perform Quality/Operations checks and log applicable manufacturing and monitoring data
  • Identify nonconforming materials and facilitate related actions per system requirements
    • Attend shift production meetings to understand production priorities and incorporate them into daily scheduled activities in a manner that maximizes commitment to customer delivery
    • Maintain and catalogue production data, from process monitoring activities, into applicable databases
    • Monitor indicators for Quality of product in all areas for all manufacturing operations in the facility
    • Actively partner with cross-functional Engineering teams and team-members to find problem solving solutions
    • Perform final production verifications/confirmations including batch/lot reconciliation to DHR records
    • Manage batch retains for inventory and perform retain verification, as needed
    • Generate and maintain reports from Quality Check data sources
    • Perform verifications/confirmations for accuracy of final materials accountability for scrap, WIP, and final material, to include relief calculations and data entry
    • Monitor the accuracy and content of consumption error reporting on an as-needed basis, to ensure correct material control, and exception resolution as required
  • Support independent verification and maintenance of employee manufacturing training records.
  • Support the maintenance and scheduling of equipment Calibrations (internal & external) and Preventive Maintenance.
  • Execute special projects & site initiatives, as assigned by Management
  • Participate/contribute to in Continuous Improvement projects
  • Other duties and responsibilities as assigned
  • Perform legal and factual research, along with records research.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High School Diploma or G.E.D.
  • Technical Program / Associate Program / Advanced Education preferred
  • Strong basic Math skills.

TECHNICAL EXPERIENCE:

  • Experience in a manufacturing environment (Machining, Stamping, Coiling, Assembly, Laser, EDM, Secondary Operations, & Quality Controls).
  • Regulated industry (Automotive, Aerospace, Medical Device, etc.) experience preferred.
  • Knowledge and experience with Quality manufacturing standards (cGMP/QSR, Good Documentation Practices, Line Clearance, Production Control).
  • Solid English verbal and written communication skills. Ability to document and explain complex scenario data to internal partners and supervisors.
  • “Hands-on” self-starter with ability to work both independently as well as part of a team.
  • Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and/or database entry.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT:

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Team Leader

Summary:

This position is primarily responsible to motivate the team to meet production, quality goals, and objectives.  Provide complete, timely, and informative communication to all shifts.   Ensure that Production Control schedule is followed and contribute to all teams achieving monthly production schedules and quality goals.

Responsibilities:

  • Assesses risks and seeks appropriate assistance from Production Manager/Supervisor
  • Ensures safety guidelines are understood and followed at all times
  • Resolves production problems and documents issues for discussion in meetings with Management, Engineering and Quality
  • Recommends operational changes to Production Manager/Supervisor
  • Gives and receives employee feedback
  • Identifies training and cross-training needs and ensures completion of training records for work cell.
  • Facilitates team participation
  • Ensures material transactions are documented and communicated to Production & Inventory Control as needed to support accurate inventory counts
  • Shop cleanliness and tidiness: Work cell is responsible for cleaning the area on a daily basis in accordance with established procedures
  • Will have authority to shut down production for out of control situations, contact necessary personnel to solve problems, request additional resources and move resources to other areas for temporary assignments
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • High school diploma or GED.
  • Minimum 5 years’ experience in a progressive manufacturing environment.
  • Prior experience in a Contract Manufacturing Operation (CMO) is preferred.
  • Relevant experience in leading team performance and regulatory compliance.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT:

Work is performed in a manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Sr. Process Development Engineer

Summary:

This position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Lead PE representative on project.  Provide input on resources needed and project planning.
  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients on projects of moderate complexity.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets.
  • Provide guidance and direction to coworkers on areas of technical expertise.
  • Troubleshoot production processes as required.
  • Evaluate and select appropriate test methods for product requirements.
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection
    • Process development and documentation
    • Device Verification samples and testing
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging.
    • Materials sourcing and device prototyping.
    • Design verification and validation activities, including data for regulatory submission.
    • Manufacturing transfer and support of existing product lines as applicable.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Willingness to travel, if required.
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills.
  • Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures.
  • Must be able to read, write and speak fluent English.
  • A Bachelors’ degree in an engineering discipline with 5 years of relevant experience; Associates degree in an engineering discipline w/10 years of relevant experience; or equivalent.
  • Experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.
  • Strong analytical skills, must be able to obtain and evaluate secondary research information.
  • Ability to learn and apply new technology.
  • Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT:

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Production Supervisor

Summary:

This position is primarily responsible to direct the development and implementation of activities in production area(s) to meet production goals, quality, and cost objectives. Plan, organize and schedule production activities to meet customer demands. Provide direction, leadership and motivation to production personnel, including training and assistance with adhering to the quality system.

Responsibilities:

  • Provide leadership and direction across the associated shift ensuring proper levels of production and quality are met.
  • Responsible for ensuring conformance to all company policies, procedures and work instructions.
  • Plan, organize, and schedule production activities (including personnel and equipment) to meet schedules for both standard production and development projects.
  • Maintain production goals and deadlines. Preemptively coordinate material and system requirements to ensure minimum amount of downtime and recommend measures to improve production methods, yields, and the quality of product.
  • Manage production personnel, including planning personnel needs, participating in the hiring process, and managing performance.
  • Conduct daily team meetings for proper communication and development of production team.
  • Develop in depth knowledge of production processes and associated equipment, including laser workstations and CNC motion control programs. Troubleshoot manufacturing issues as part of maintaining production schedule and developing self-reliance among production technicians.
  • Contribute to development, maintenance, and follow up of production metrics.
  • Plan, implement, and maintain the production environment with focus on safety, cleanliness, and organization.
  • Participate on and lead teams that improve safety, quality, and reliability in the production area, as well as teams that support cost saving and team building initiatives (QDC).
  • Plan and implement technical skills training for production personnel, including generic and product specific skills. Act as trainer when necessary.
  • Understand the requirements of and ensure compliance with the preventative maintenance program.
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Be able to read, write and speak fluent English.
  • Associates degree or equivalent experience in a related field.
  • Computer literate (MS Office Suite, Syteline).
  • Understanding and implementation of Lean Manufacturing and Six Sigma for process improvement and problem solving.
  • Strong knowledge of ERP/MRP business functions.
  • Able to prioritize and manage multiple responsibilities.
  • Must be able to read blueprints and interpret technical specifications and illustrations.
  • Experience in technical report writing and verbal communication skills.
  • Minimum 3+ year’s supervisory experience in a manufacturing environment, preferably in a medical device manufacturing environment and in leadership role.

PHYSICAL DEMANDS:
While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT:

Work is performed in a manufacturing environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Buyer/Planner

Summary:

The Buyer Planner creates and owns material plans in support of production needs. The Buyer Planner generates purchase orders and manages supplier deliveries. The Buyer Planner is responsible for the availability and flow of produced and purchased materials.

Responsibilities:

  • Create, maintain, and improve material and production plans and schedules
  • Plan and execute purchase orders to support production plans and financial goals
  • Drive improvements in schedule attainment and inventory velocity
  • Establish and maintain secure and dependable relationships with internal and external suppliers
  • Ensure best in class service and pricing from preferred suppliers
  • Other responsibilities as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Demonstrated purchasing and supplier management background
  • Experience in planning and scheduling techniques to drive on time delivery to Customers
  • Understanding of ERP/MRP based planning systems and lean manufacturing principles
  • 3 – 5 years relevant manufacturing experience required in medical, pharma and or similarly regulated industries
  • Bachelor’s degree and or APICS/ASCM certification
  • Knowledge of Supply Chain Management concepts and processes
  • Strong interpersonal communication skills including in-person and virtual

WORKING ENVIRONMENT

Work is performed in an office environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position. Occasional overnight travel may be required up to twenty percent.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Thin Film Process Development Engineer

Summary:

This position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • May serve as a primary contact with clients on projects of low to moderate complexity.
  • Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
  • Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Have input to project manager for tracking and communicating project status, plans, issues, timelines, action items, and budgets.
  • Responsible for the following project inputs:
    • Feasibility builds, documentation, and testing
    • Equipment selection, and technology identification in support of high-volume manufacturing of thin film devices
    • Process development of, metallization system using thin film deposition and plating methods
    • Development of photolithography and etching processes (wet and dry)
    • Process Failure Mode Effects Analysis
    • Prototype builds
    • Process Validation
  • Involvement in the full design, development, and validation requirements of projects, including:
    • Product design and specification creation
    • Materials sourcing and device prototyping
    • Design verification and validation activities, including data for regulatory submission
    • Manufacturing transfer and support of existing product lines as applicable
  • Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

  • Willingness to travel, if required.
  • Must maintain high ethical standards
  • Must demonstrate good organizational skills.
  • Must be able to read, write and speak fluent English.
  • A Bachelor’s degree in an engineering discipline and minimum 4 years appropriate work experience; or Associate’s degree in engineering discipline and a minimum or 6 years appropriate work experience; or a minimum 10 years relevant work experience; or equivalent.
  • Experience in an engineering and cleanroom manufacturing environment with a focus on mechanical, photolithography, wet and dry etching manufacturing processes.
  • Experience with thin film metallization deposition equipment and customer process development.
  • Experience with manual and automatic photolithography equipment and development of custom processes.
  • Experience developing wet and dry etching processes.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • Strong analytical skills, must be able to obtain, evaluate, and apply secondary research information
  • Ability to learn and apply new technology.
  • Technical report preparation and formal presentation skills.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

General Referral Application

General Referral

Don’t see a position that fits your background and experience? We are always accepting applications and resumes that we keep on file. If we open a new position that better fits your background and experience we can review your general referral application.

APPLY NOW – or email CareersAtCirtec@Cirtecmed.com