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

Engineering Technician

Summary:

This position is primarily responsible for utilizing state of the art equipment for the development of life changing medical devices.  The ideal candidate will be comfortable operating a variety of equipment including, but not limited to; lasers, injection molders, reflow machines as well as an array of test equipment while adhering to the quality requirements of the company. In addition, this position will work with the design and process teams to ideate, create, and build first prototypes. This individual is essential in the maturation of these prototypes and their progress through the development.   Lastly, the technician must feel comfortable providing candid feedback to the development team to ensure success in later phases of the program.

Responsibilities:

  • Run equipment tests, collect data and analyze data with the engineering team.
  • Make recommendations on how to improve the quality or efficiency of a process based on data and observation.
  • Ability to diagnose and solve problems with jobs in a timely manner.
  • Assist in training employees on equipment and assembly skills.
  • Interact effectively and assist engineering in improving quality and solving problems.
  • Develop processes and procedures for projects to improve quality and cost.
  • Originate and maintain written technical descriptions of processes and procedures comprehensive in scope and understandable by the audience.
  • Represent engineering for Material Review Board concerning material dispositions.
  • Represent Engineering 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.
  • Prepares Engineering Change Orders for processes and components.
  • Performs Corrective and Preventative Action tasks.
  • 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:

  • Strong drive to learn, share and teach.
  • Understanding of and experience with mechanical equipment.
  • FDA, cGMP principles and practices, (ISO 9001, ISO 13485).
  • 3 Plus years’ experience in the engineering/manufacturing environment for medical devices.
  • In-depth understanding of one or more manufacturing processes is a plus.
  • Familiarity with Pro-E / CREO and or SolidWorks is preferred.
  • Strong computer skills associated with Microsoft software.
  • Ability to interpret technical drawing, blueprints, specification and illustrations.
  • 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 strong team collaboration skills.
  • Must be able to make clear and accurate decisions.
  • Strong desire to learn and apply new technology.

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

Sr. Process 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

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

Tool Grinder

Summary:

This position is primarily responsible for producing the highest quality tool’s in our medical manufacturing facility.

Responsibilities:

  • Set-up and Operate CNC tool grinding machines, using blueprints, job orders, and knowledge of abrasives and metal properties.
  • Program CNC tool grinding machines.
  • Clean and conduct general maintenance to department machines.
  • Select ,True and Dress Diamond wheels.
  • Create close tolerance, carbide micro tooling, from solid blanks.

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 years, Set-up 6 axis tool and cutter grinders with pallets.
  • Programming with conversational and M&G formats.
  • Familiar with Rollomatic and TTB machines.
  • Quick turn Manual grinding.
  • Knowledge of Manual and Automatic wheel dressing.
  • Knowledge of balancing wheel packs.
  • Inspection with usage of microscope, shadow, vision systems, micrometers.
  • Must be able to read, write and speak fluent English.
  • Must be able to convert inch to metric.

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

Sr. Systems Engineer

Summary:

Based out of our headquarters in Brooklyn Park, MN, the Sr. Systems Engineer will be mainly responsible for system-level development and implementation of electronic and software designs for medical devices, that include Class II and III.  The System Engineer will work on systems integration of hard and software of multiple medical device projects and customers. 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 coordination of multiple projects to ensure timely and successful completion. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, communication, organizational, flexibility and professional.

Responsibilities:

  • Create requirements, engineering specifications, tests during the life cycle of the product development.
  • Knowledgably of applicable medical development standards, such as IEC 60601-1, 62304, 60601-1-2, ISO 14708-1, 14708-3, ISO 13485.
  • Ensure that all hardware and software requirements and specifications are being met, and that all elements are being developed to maximize performance, reliability and serviceability within the constraints of the project schedule and budget.
  • Perform detailed design analysis and conduct regular design reviews with hardware and software engineering teams.
  • Collaborate with program managers to create and manage development plans and project plans related to electronic and software systems development.
  • Lead and contribute in creation of risk management documentation, including Failure Mode Effects Analysis.
  • Develop and maintain documentation (for e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files Manage and assist in creation of ­manufacturing process instructions, bills of material, quality inspection, and related documentation.
  • Create, review test software requirements, architecture, develop and executing the test code.
  • Knowledge of Quality Management System principles and methodology.
  • JAMA Product Development Documentation Management a plus.
  • Participate in product development meetings and software/hardware design and risk analysis reviews.
  • Specify and assemble hardware for tests.
  • Maintain design history file and participate in periodic phase reviews.
  • Create reports to the stakeholders and create test logs.
  • Provide inputs to the team in order to improve the medical device design and test outcomes.
  • Use a thorough, systematic, open approach to problem-solving.
  • 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.

Requirements:

  • BS in Electronics or Computer Engineering or in an equivalent engineering discipline.
  • Advanced degrees preferred.
  • Minimum of 5 years’ experience in active and passive implantable devices, peripherals for medical devices.
  • Class III medical device experiences preferred.
  • Meticulous attention to detail, including ability to maintain accurate records and traceability.
  • Experienced in electronics; analog, power and digital, oscilloscopes, general electronic test equipment.
  • Experienced of Quality Control principles and methodology.
  • Good Communication and interpersonal skills.
  • Analytical reasoning and problem solving.
  • Experience in developing requirements, engineering specifications, procedures.
  • Team player and goal oriented.
  • Agile, Scrum, knowledge.
  • Excellent oral, written, and presentation communication skills.
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. 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

Vice President Quality Assurance & Regulatory Affairs

Summary:

As the VP of RA/QA, you will be responsible for the management, development, implementation and coordination of the regulatory affairs and quality assurance functions with a focus on understanding, implementing and ensuring compliance with global quality/regulatory requirements for Cirtec Medical. The successful candidate will build a flexible and knowledgeable team able to develop and execute quality and regulatory strategies tailored to the needs of each customer in a broad risk spectrum of product categories.

Responsibilities:

  • Manages and direct all areas of Regulatory Affairs, Quality Systems and related customer communication.
  • Develops, implements, and maintains required Regulatory compliance with all requisite regulatory agencies, including, but not limited to, U.S. FDA, EU/ISO, Canadian, Asia-Pacific and Latin America regulations.
  • Maintains current working knowledge of FDA and global regulatory requirements, and keeps Management apprised of new developments and potential impacts to our customers and the organization.
  • Establishes and executes processes to provide customers with Regulatory Affairs support, including preparation and planning of submissions.
  • Ability to interact with Global Regulating Agencies (FDA, Notified Bodies, etc.) to secure product approvals and define Regulatory strategies. Respond to requests from regulatory agencies. Leads in the creation of reports and documentation needed for regulators.
  • Designs and implements programs, policies, and practices to ensure Quality Assurance, GMP compliance, and lead a quality culture within the organization.
  • Responsible for and leads all aspects of the company’s ISO and FDA compliance.
  • Manages strategy and approach for all inspection/audits in compliance with local and global regulatory agencies and with customers.
  • Provides Quality Assurance oversight of vendors; prepare and maintain quality agreements. Promotes and maintains Certified Supplier programs, including required audits.
  • Responsible for CAPA, Non-conformance Reporting, deviations, and product complaint investigations.
  • Facilitates improvement in quality tools and techniques including SPC and provides quality and statistical expertise to team.
  • Manages changes in systems or procedures when necessary. Develop appropriate change and communication approach as needed.
  • Provides sponsorship and acts as change facilitator for APC, FMECA, DOE and process validation.
  • Develops and manages departmental strategic plans, tactics, and budgets.
  • Promotes organization to customers around the world and fosters customer/industry relations.
  • Other responsibilities and 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 15 years of experience in a medical device environment in increasing leadership roles, preferably in a Regulatory Affairs or Quality, with supervisory and decision-making responsibilities.
  • Bachelor of Science, preferably in an engineering discipline (Master’s Degree preferred.
  • Quality/Regulatory Certifications (preferred).
  • Experience in managing regulatory submissions for CL II and CL III active implantable products.
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), especially pertaining to product development, manufacturing, supplier management, quality control 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.
  • Strong verbal and written communication skills; ability to present complex data to internal and external contacts.
  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines, while increasing employee engagement and retention.

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 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

Quality Control Inspector

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 first shift.

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

VP/GM of Engineering Services

Summary:

The Vice President and General Manager (VP/GM) of Engineering Services is fully responsible for the P&L of the Global Engineering Services organization.  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 oversees an organization consisting of over 130 personnel across a wide range of program management, engineering disciplines, design quality and supply chain located at 5 different sites.  The VP and 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. VP/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-9000 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.
  • Must possess effective decision-making skills and analytical ability.

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

Test Station Engineer

Summary:

This position is primarily responsible for developing test code, writing test protocols, code, executing for active and passive implantable/external medical devices, mobile applications and embedded medical devices. Requires close communication with the product development team to track testing status, regression testing and documentation. 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 coordination of multiple projects to ensure timely and successful completion. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, communication, organizational, flexibility and professional.

Responsibilities:

  • C# and UI development experience to create programs for medical device production floor operators
  • M2M and SQL databases
  •  Create interfaces to MICS base stations and implants
  • Create, review test software requirements, architecture, develop and executing 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 station
  • 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:

  • 5-7 years’ experience in testing active implantable devices, hand-held devices and test equipment used for testing medical devices.
  • Working knowledge in electronics; analog, power and digital, oscilloscopes, general electronic test equipment.
  • Knowledge of Quality Control principles and methodology is an asset
  • Good Communication and interpersonal skills
  • Analytical reasoning and problem solving
  • Experience in developing test code instructions and procedures
  • C#, LabVIEW, National Instruments TestStand, SQL
  • Develop user, system and process documentation IQ, OQ, PQ
  • Agile development, scrum master
  • Familiarity with medical development standards such as IEC 60601-1, 62304, 60601-1-2,  ISO 14708-1, 14708-3
  • Excellent oral, written, and presentation communication skills
  • Bachelor’s Degree preferable in Electrical/Electronic/Biomedical/Computer Engineering or extensive professional experience in AIMD testing
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

Program Manager

Summary:

The Program Manager, based out of our Enfield, CT facility, will be mainly responsible for managing and coordinating development and manufacturing transfer of complex Class II and III medical devices.

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.

Responsibilities:

  • Manages and coordinates development and manufacturing transfer of complex Class II and III medical devices such as active implants, minimally invasive surgical devices and external medical devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute activities based on well-defined prioritization.
  • Coordinates activities across different functional groups to ensure successful completion of program goals and milestones.
  • Tracks program 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 program 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.
  • Contributes to development, quality and risk management activities, and acts as backup to engineers and technical staff on assigned programs as required.
  • Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
  • Manages internal resources to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
  • Assists business development team with definition of program scope, timeline, and budget to support preparation of proposals, quotations, and change orders for customers.
  • 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 neuromodulation devices, Implantable Pulse Generators (IPGs) and/or implantable lead assemblies preferred but not required.
  • Demonstrated ability to lead medical device development projects from design through verification / validation, and transfer to production.
  • 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.

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law.  Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

EEO/AA/D/V

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

Shipper/Receiver

Summary:

This position is primarily responsible for the shipping and receiving of materials, verifies and maintains accurate records of incoming and outgoing shipments according to company’s Quality System Procedures, assists with inventory control and management,  performs cycle counting, kits and issues materials to production job orders, and orders production consumable supplies as required.

Responsibilities:

  • Receive customer supplied and/or purchased materials.  This includes proper labeling, storage and documenting movement of materials.
  • Unpack, examine and route incoming shipments, reject damaged items and record shortages.
  • Performs ERP transactions necessary to track movement of goods prior to acceptance into inventory.
  • Generate required documentation for domestic and international shipments.
  • Monitor inventory levels of production consumables and place orders as necessary.
  • Maintain adequate inventory of shipping materials and supplies.
  • Place orders for R&D materials as assigned.
  • Receive and process all defective products returned for repair, investigation or credit.
  • Schedules Shipper/Courier pickups as required.
  • Maintain the work area and equipment in a clean and orderly condition.
  • Follow prescribed Safety Regulations.
  • 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.
  • Minimum of 3-5 years shipping/receiving experience preferably in a regulated industry.
  • Fluent and literate in English.
  • Experience with computers and computer software programs. (i.e. FedEx application)
  • Ability to read and interpret technical documentation.
  • Capacity to work well under pressure and take on new challenges.
  • Organizational and time management skills.
  • Ability to work to tight deadlines.
  • Awareness of health and safety issues as they relate to the device manufacturing.
  • Ability to work independently using available resources.
  • Previous experience with FDA standards, ISO 13485 and GMP principles.

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 required to stand, and/or walk.  The employee must occasionally lift and/or move up to 30 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

Site Quality Manager

Summary:

This position will be responsible for the Leadership and management of all site-level Quality-organizational personnel and resources to ensure adherence and compliance to Cirtec Medical’s Quality Management System. The Site Quality Manager shall be the designated Site-Level Management Representative for the Quality Management System of their assigned Cirtec Medical Facility.

Responsibilities:

  • This position may have multiple direct-reporting subordinate Managers and Supervisors in addition to having direct-reporting responsibilities for daily activities of site Quality personnel (responsibility dependent on geographic organizational structure).
  • 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 organizational Quality Leadership, coaching, mentoring and guidance to all Quality personnel as well as cross-functional teams.
  • Support for integration of new manufacturing capabilities, product transfers, development programs and manufacturing customers.
  • Provide Leadership and Guidance for site-level Quality functions including Documentation Control and records retention, Complaint Handling/Returns, Corrective and Preventive Actions, Training, Supplier Quality Management, Nonconforming Material Handling, and Metrology/Calibration Control Systems.
  • Provide oversight and ensure compliance of Quality System support elements for the site QMS: Internal Auditing, Supplier Quality Management, Complaint Handling, Corrective and Preventive Actions, Nonconforming Materials Controls; and the tracking & reporting of associated metrics.
  • Act as site-level Champion for Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Provide Leadership and Guidance for site-level Quality functions including incoming (Receiving & Inspection), in-process inspection, final inspection, and product release support.
  • Provide Leadership and Guidance for site-level Design and Development programs, Sustained Manufacturing and Continuous Improvement/Continuation Engineering activities and initiatives.
  • Provide Leadership and Guidance for Risk Management (Hazard Analysis and Assessment – Design & Process), Design and Limit Characterization, and Process Qualification (DV&V and PV).
  • Oversee and coordinate site auditing activities (Customer and Customer Regulatory Agencies).
  • Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.
  • Administration of employment practices, including, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees. Responsible to ensure these actions are performed in compliance with Federal and local laws as well as Cirtec Medical policies.
  • 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.

Qualifications:

Required Education & Experience:

  • 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.

Preferred Qualifications & Experience:

  • Advanced Post-Secondary Education/Training/Certification coursework
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • 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 (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Technical Requirements, Skills and Training:

  • Experience in coaching and developing subordinates, utilizing performance management tools and disciplines while increasing employee engagement and retention.
  • Strong verbal and written English language communication skills.
  • Successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements.
  • 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.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Los Gatos, CA

Manufacturing 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.

Based out of our facility in Los Gatos, CA, the Manufacturing Engineer will be mainly responsible for manufacturing process development, launching new products into clinical and/or pilot production and supporting sustained production.

Responsibilities:

  • Develops and implements robust cost-effective manufacturing processes, and improves product flow and product quality and safety performance for both sustained and new products
  • Leads design transfer of new products to production including establishing assembly time and yield targets, training needs and quality control
  • Develops, tests and implements tools, fixtures and equipment required for manufacturing processes
  • Develops manufacturing process instructions, inspection plans and lot history travelers
  • Leads creation of manufacturing process validation plans, validation protocols and reports, and implements manufacturing process validations and test method validations
  • Collaborates with cross-functional teams during development phase(s), and provides inputs and recommendations for design for manufacturability (DFM)
  • Develops and maintains process risk documentation (e.g. PFMEA) to identify potential risks, and implement preventive and corrective actions
  • Manages and/or supports production and test equipment maintenance, qualification and calibration
  • Performs analysis for cost reduction, and quality and efficiency improvement
  • Prepares engineering change orders and coordinates the implementation of changes including training production staff
  • Troubleshoots designs and processes when defects occur, leads investigation to determine root cause and implements effective containment and counter measures
  • Dispositions non-conforming products and develops required re-work procedures
  • Communicates with customers regarding process improvements and production changes
  • 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:

  • BS in Mechanical / Industrial Engineering or in an equivalent engineering discipline
  • 5+ years of experience in medical device process development and/or manufacturing engineering
  • Experience with capital electromechanical products (involving circuit boards and displays) preferred
  • Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies preferred
  • Solid knowledge of GMP and ISO 13485 regulations
  • Must be able to review and interpret technical drawings and specifications. Proficiency in Solidworks preferred.
  • Strong computer skills, including the MS Office suite
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
  • Must have demonstrated organizational skills to manage multiple priorities and schedules

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

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

Sr. Design & Development Quality Engineer

Summary:

This position is primarily responsible for Design Control (product development), Regulatory compliance, qualitative and quantitative data analysis, complaint investigation and analysis, Manufacturing support, Training, Metrology and Gage R&R, and other Quality functions. Additionally, this role is expected to provide input and contribute on Quality System strategies and approach.

Responsibilities:

  • Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System.
  • Author and execute Quality Plans for Quality Product Design and Development projects.
  • Initiate the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments per project requirements.
  • Establish severity and risk-based Design Verification and Process Master Validation Plan strategies with appropriate V&V rationales.
  • Support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
  • Drive Test Method development (w/ Operational and Business considerations) and execution of Test Method Validations to measure effectivity.
  • Provide direction in implementing Incoming, In-Process and Final Product Inspection plans.
  • Develop and justify appropriate sampling plans with characterization of test/inspection methods.
  • Champion First Article Inspections and Component Qualifications.
  • Author, review and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams per project requirements.
  • Represent Quality Engineering in design and phase reviews throughout the product development process.
  • Support initial qualification audit activities (Customer and Regulatory Agencies).
  • Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
  • Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NCMR’s, as applicable.
  • Ensure compliance of all site personnel to Corporate and site-level QMS and training requirements.
  • Administration of employment practices, which includes, but is not limited to, monitoring time & attendance, hiring, terminating, counseling and disciplinary actions for all employees.  Responsible to ensure these actions are performed in compliance with Federal, local, and organizational laws/policies.
  • Member of customer and 3rd party quality audit team.  May be required to lead this effort.
  • Provide Engineering Technical Expertise and Guidance for site-level Quality functions.
  • 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:

Required Education & Experience:

  • Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 4-6 years’ experience in a regulated manufacturing environment.

Preferred Qualifications & Experience:

  • Advanced Post-Secondary Education/Training/Certification coursework.
  • Quality certification(s) (e.g. ASQ CQT, QCI, etc.)
  • Class I, II and/or III Medical Device manufacturing experience.
  • Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.)
  • 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 (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.

Technical Requirements, Skills and Training:

  • Experience in effectively supporting audits by customers and external regulatory agencies.
  • Strong verbal and written English language communication, organizational, and management skills.
  • Successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements.
  • 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.
  • Demonstrated use of Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, and Gauge R&R.

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

 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

Industrial Engineer-Continuous Improvement

Summary:

The Industrial Engineering (IE) role in the Operational Excellence group is a key member of the organization. The IE is responsible for identifying and leading execution of a wide range of Continuous Improvement projects using industry best practices in Lean and Six Sigma approaches.  He/she leads, facilitates, executes, and manages team training initiatives and projects to reduce waste, cost and variation through use of Lean and Six Sigma tools and methodologies. He/she will utilize his/her knowledge of COGs, gross margin, facility design, material handling equipment, labor management, staff planning and project execution to identify, prioritize and recommend improvement projects and training modules 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 productivity, quality, process efficiency, space utilization, standard updates and lead time improvement efforts for existing and new product development programs.
  • 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 to 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.
  • Be a learner; adaptable to accept new changes in the field of lean manufacturing and desire to remain knowledgeable with regard to 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, 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 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

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