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

Sterilization Engineer

Summary:

This position is responsible for technical execution of activities associated with projects in the global sterilization network to improve operational efficiency, ensure predictable product flow, and enable lowest total cost of ownership.

Responsibilities:

  • Subject Matter Expert for in-house and external Ethylene-Oxide (EO) sterilization services.
  • Provide organizational technical support for in-house and external sterilization, maintaining flow of Design/Development programs and Sustained Manufacturing product lines.
  • Lead development, review and approval of load configurations, Process Challenge Devices, sterilization validations, and product family adoptions.
  • Support sterilization chamber equipment qualifications & equivalencies and routine re-qualification/re-validation activities.
  • Develop and optimize sterilization cycles with the intent of improving cycle times, reducing lead times, and improving internal operating costs.
  • Oversee routine bioburden and environmental monitoring programs and assessing residual impact to sterilization validation status.
  • Coordinate external testing for test method development, cycle validations and routine bioburden and environmental sampling.
  • Coordinate external verification testing for Biological Indicators.
  • Develop Standard Operating Procedures, Manufacturing Work Instructions, Test Methods and provide on-site training to applicable technical staff.
  • Establish preventive maintenance programs for sterilization, requalification, product loading, and material handling.
  • Develop and maintain knowledge of applicable industry standards and regulations for sterilization.
  • Assure compliance with Federal, State and local safety/environmental regulations. Assist in environmental testing and reporting.
  • 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:

  • Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Biological discipline preferred).
  • Minimum of 3-5 years’ experience in a medical device sterility assurance, sterilization operations or testing environment.

Preferred Qualifications & Experience:

  • Advanced Post-Secondary Education/Training/Certification coursework
  • 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:
  • 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

NPI Buyer

Responsibilities:

  • Vendor selection, qualification and development.
  • 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 and or components or services to sustaining buyers.
  • Support project and program teams as key sourcing resource.
  • Work with Engineering and review new item masters to ensure item masters are set up correctly to maintain proper finance, inventory and purchasing guidelines.
  • 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:

  • Demonstrated supply chain creation, management and improvement experience.
  • A record of creating and improving vendor relationships.
  • Ability to read and interpret technical specifications, prints and requirements.
  • 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.

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

Project Manager - Supply Chain

Responsibilities:

  • Project Management with a focus on supply chain creation for strategic programs.
  • Create resilient and scalable supply chains to ensure quality and delivery at best in class costs.
  • Integrate supply chains into execution teams with seamless handoffs.
  • Serve as core team member for strategic programs.
  • 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:

  • Demonstrated supply chain management and improvement experience.
  • A record of creating and improving supply chains.
  • Minimum of 5 years’ experience in contract and or medical device manufacturing with project and or program management 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 and managing with ISO 9001 and ISO 13485 procedures preferred.

PHYSICAL DEMANDS

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

Protective Clothing Required: 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

Principal Mechanical Design Engineer (Nitinol)

Summary:

Defines, develops and designs implantable medical devices that utilize Shape Memory Alloys (SMAs). Owns efforts in developing solutions to product design, and design for manufacturability for these products and other Class II and III active implantables. Able to multitask and run multiple projects meeting customer commitments while anticipating customer needs. Effectively communicate to all levels of the organization.

Responsibilities:

  • Responsible for product system design and ensuring that products developed meet both internal and external customer requirements.
  • Utilize design, analysis, and statistical tools, including SolidWorks, Minitab, DOE, Measurement System Analysis, Gage R & R, Process Capability, and Confidence & Tolerance interval analysis.
  • Provides regular status updates to management and or customer.
  • Provides work direction to team members that may include other engineers or technician level team members.
  • Leading and/or participating in DFMEA, PFMEA, and risk analysis activities.
  • Performs design reviews and pre-verification assessments to ensure design outputs will be met.
  • Writes/updates part specifications, mechanical drawings, and various technical documents.

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:

  • 5-7 years of experience in the medical device industry with responsibility for designs, materials, and processes.
  • SolidWorks experience.
  • Excellent reading, writing, communication, and organizational skills.
  • Experience/Expertise in experimental techniques including statistical analysis, DOE and tolerance analysis.
  • A BS degree in relevant engineering discipline.

Desired Requirements:

  • Experience designing medical devices that utilize SMAs or similar materials.
  • Understanding of processing, specification development, and end uses of SMA products.
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Principal Mechanical Design Engineer (IPG)

Summary:

Defines, develops and designs implantable pulse generators (IPGs) and other Class II and III active implantable devices. Owns efforts in developing solutions to product design, and design for manufacturability. Able to multitask and run multiple projects meeting customer commitments while anticipating customer needs. Effectively communicate to all levels of the organization.

Responsibilities:

  • Responsible for product system design and ensuring that products developed meet both internal and external customer requirements.
  • Utilize design, analysis, and statistical tools, including SolidWorks, Minitab, DOE, Measurement System Analysis, Gage R & R, Process Capability, and Confidence & Tolerance interval analysis.
  • Provides regular status updates to management and or customer.
  • Provides work direction to team members that may include other engineers or technician level team members.
  • Leading and/or participating in DFMEA, PFMEA, and risk analysis activities.
  • Performs design reviews and pre-verification assessments to ensure design outputs will be met.
  • Writes/updates part specifications, mechanical drawings, and various technical documents.

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:

  • 5-7 years of experience in the medical device industry with responsibility for designs, materials, and processes for electro-mechanical implants or external devices.
  • SolidWorks experience.
  • Excellent reading, writing, communication, and organizational skills.
  • Experience/Expertise in experimental techniques including statistical analysis, DOE and tolerance analysis.
  • A BS degree in relevant engineering discipline.

Desired Requirements:

  • Experience designing Implantable Pulse Generators or similar devices.
  • Understanding of standards and requirements related to Implantable Pulse Generators or similar devices
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Mechanical Design Engineer

Summary:

Defines, develops and designs medical devices and related accessories. Owns efforts in developing solutions to product design, and design for manufacturability. Able to multitask and run multiple projects meeting customer commitments while anticipating customer needs. Effectively communicate to all levels of management and production personnel. Prioritize tasks based on direction given by management to ensure all project deliverables are completed successfully.

Responsibilities:

  • Responsible for product system design and ensuring that products developed meet both internal and external customer requirements.
  • Utilize design development, analysis and statistical tools, including SolidWorks, Minitab, DOE, Measurement System Analysis, Gage R & R, Process Capability, and Confidence & Tolerance interval analysis.
  • Provides regular status updates to management and or customer.
  • Provides work direction to team members that may include other engineers or technician level team members.
  • Leading and/or participating in DFMEA, PFMEA, and Risk analysis activities.
  • Performs design reviews and pre-verification assessments to ensure design outputs will be met.
  • Writes/updates part specifications, mechanical drawings, and various technical documents.

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:

  • 3-5 years of experience in the medical device industry with responsibility for materials, designs, and processes on electro-mechanical implants or external devices
  • SolidWorks experience
  • Excellent reading, writing, communication, and organizational skills
  • Experience/Expertise in experimental techniques including statistical analysis, DOE and tolerance analysis
  • A BS degree in relevant engineering discipline
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Process Development Engineer (Nitinol)

Summary:

This position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Focusing on manufacturing with Nitinol, design of Nitinol components and adjacent tooling, this role is also involved in the documentation and validation 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:

  • Production lead for driving eligible processes through the transfer from development to production.
  • 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 deliverables:
    • 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.

Requirements:

Nitinol manufacturing and/or design experience.

  • 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 5 years appropriate work experience; or Associates degree in engineering discipline and a minimum or 7 years appropriate work experience; or a minimum 10 years relevant work experience; or equivalent.
  • Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • 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.

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

Cost Accountant

Summary:

The Cost Accountant works closely with the Operations Controller as the subject matter expert on all cost accounting activities for the company, ensuring an accurate representation of product and manufacturing costs and expenses on the company’s financial statements.

Responsibilities:

  • Identify, analyze, and report variances in product costing, job costing and production activities. Review labor and overhead application and variances.
  • Collaborate with manufacturing, supply chain, and quality leaders with efforts to reduce costs, variances, customer returns, and manufacturing scrap.
  • Establish and execute cost controls for item masters, bills of materials, work centers, and job travelers.
  • Assist our sales engineers in producing customer quotes to ensure all costs are captured and appropriate profit margins are maintained.
  • Perform monthly account reconciliations, analysis, and reporting for inventory, WIP, and variances. Also provide gross margin analysis per product line and customer.
  • Provide support for year-end and other 3rd party audits of our inventory. This will include the identification of slow-moving and obsolete inventory and communicate recommendations for the valuation and disposition of these items.
  • Assist with the budgeting process for cost and product related valuations and estimates. Provide explanations of variances and deviations of the current budget to the actual results.
  • Support IT initiatives with system improvements, upgrades and/or conversions. Act as accounting representation in cross-functional teams to properly develop and execute cost and manufacturing transaction procedures to maximize the efficiency and use of our resources.
  • Assist with capital expenditure requests by providing return on investment analysis as needed.
  • Perform other related duties as assigned by management.
  • Other duties as assigned.

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

Requirements:

  • Bachelor’s degree in accounting or related field
  • Excellent analytical and communication skills
  • High level skills with ERP systems
  • Proficient use of Word, Excel, and Outlook
  • Must be self-motivated, and the ability to work independently with minimum supervision

PHYSICAL DEMANDS

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

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Applications Engineer

Summary:

The Senior Applications Engineer will serve as principal technical contact with external customers during the business development process and will be mainly responsible for defining scope, timeline, and budget for new medical device development programs / projects.

Responsibilities:

  • Serves as the principal technical contact with external customers during the business development process and participates actively with business development team to engage new customers to specify project / product requirements and effectively communicate Cirtec’s capabilities to customers
  • Leads definition of scope, timeline, and budget for new development programs and prepares budgetary project plans, development proposals and quotations for new and existing customers
  • Collaborates with the engineering teams to coordinate integration of existing individual processes and platform capabilities to facilitate product development process
  • Understands and communicates emerging technologies, market trends, customer strategies, competitive intelligence and overall market landscape to internal stakeholders to improve company’s development and manufacturing capabilities
  • Supports program management team during program kick-off and planning phases, and assists them in preparing change orders and new quotations during development phases
  • Participates in continuous improvement of company’s design control procedures and internal business processes based on emerging industry trends
  • Communicates with strategic vendors and suppliers, and builds strong business relationships
  • 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 Biomedical / Mechanical / Electronics / Computer engineering discipline with at least 10 years of experience within the medical device industry. Experience with neuromodulation devices, Implantable Pulse Generators (IPG’s) and/or implantable lead assemblies highly preferred.
  • Must have experience working on medical device development projects from early stage 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
  • Must have proficiency in MS Office software
  • Must possess excellent written and oral communication skills in English
  • Willingness to travel, if required

PHYSICAL DEMANDS

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

Protective Clothing Required: None

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 Coordinator

Summary:

Ensure that all facility systems receive the attention required for Cirtec Medical to run unimpeded. Duties including maintenance schedules are up to date and machines are maintained properly, ensuring Cirtec’s facility is at the highest level of cleanliness and safety. Coordinate through a staff of skilled, semiskilled and unskilled labor, activities concerned with the operation, repair, maintenance, and construction of facilities, equipment, buildings and grounds to minimize interruption and improve efficiency. Carries out facilities systems repairs or may obtain bids for additional work from outside contractors if asked to by management.

Responsibilities:

  • Manage required facility and custodial documents per Cirtec’s policy
  • Perform and/or delegate janitorial duties to ensure the highest level of safety and cleanliness at Cirtec Medical
  • Safely use chemicals in the cleaning process
  • Maintain an inventory of supplies related to janitorial and facility maintenance
  • Perform plumbing and electrical repairs ae needed
  • Provide supervision/leadership to the janitorial/custodial team
  • Perform and/or delegate special projects such as carpet cleaning, wall cleaning, panting, ceiling tile repair, etc.
  • Assist in overseeing and directing contracted projects to ensure adherence to specifications
  • Promote efficiency and cost reduction
  • Provide training for the janitorial/custodial staff
  • Oversee and direct contracted projects to ensure adherence to specifications
  • Maintain compliance with local, state and federal laws
  • Inspect plant facilities or review inspection reports to determine repairs, replacement and or improvements required
  • Maintain environmental records and waste reports as required
  • Inspect chemicals and ship wastes as needed
  • Create purchase requests for needed repairs and inventory
  • Be an active part of the safety team
  • Participate in Safety Committee meetings
  • Provide safety training as needed
  • Attend trainings as needed
  • Emergency on-call duties as required
  • 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:

  • High school diploma-GED
  • Must be able to meet deadlines while the workload level fluctuates
  • Ability to life 50lbs occasionally
  • Basic computer skills
  • Effective verbal and written communication and listening skills
  • Ability to represent facilities a tactful manner
  • Ability to work with CMMA systems
  • Must be flexible to adapt to changing and varying work requirements
  • Must be able to meet deadlines while the workload level fluctuates
  • Ability to organize and prioritize
  • Ability to use chemicals safely
  • Ability to life 50lbs occasionally
  • Mechanically inclined (able to perform facility and equipment repairs)
  • Ability to use hand tools/power tools safely and efficiently
  • Detail oriented and conduct duties and repairs in a cleanly manor
  • Electric mechanical troubleshooting skills
  • Knowledge of cleanroom environments and med device a plus

Preferred:

  • 2+ years of college training in leadership/supervision or equivalent training
  • Proficient with Microsoft Office Suite and email
  • 4 years facilities experience
  • HVAC high level systems knowledge

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

Engineer Technician

Summary:

Cirtec Medical is searching for an Engineering Technician to join its Operations team. In the fast-paced medical contract manufacturing space, this position is primarily responsible to support engineering and production. Our Engineering Technicians assist Manufacturing Engineers to document processes, update documentation, implement creative ideas or solutions to improve assembly operations, and develop tooling/fixturing as needed.

Responsibilities:

  • Actively participate in improving quality and processes for the products we manufacture
  • Understand and promote good manufacturing practices (GMPs) including all clean room related requirements
  • Assist in training employees on equipment and assembly skills
  • Interact effectively and assist engineering in improving quality and solving problems
  • Show self-motivation to optimize job performance on a continual basis
  • Maintain a clean and orderly work area
  • Ability to diagnose and solve problems with jobs in a timely manner
  • Maintain compliance to procedures and regulatory requirements
  • Understand and follow safety policies and practices, attend safety training and wear PPE as required
  • 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:

  • 3+ years’ experience in the engineering / manufacturing environment of medical device component 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

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

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

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Program Manager

Summary:

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

The Senior Program Manager will be mainly responsible for managing and coordinating design and development of novel medical devices.

Responsibilities:

  • Manages and coordinates design and development of complex and novel Class II & Class III mechanical and electro-mechanical medical devices such as active implants and peripherals, surgical devices and external 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
  • Mentors and provides guidance to other program manager(s) and engineers
  • 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 a relevant engineering or science discipline with at least 10 years of experience within the medical device industry. Experience with neuromodulation devices, Implantable Pulse Generators (IPG’s) and/or implantable lead assemblies preferred but not required.
  • Minimum 5 years of experience in project / program management of medical device development programs
  • Demonstrated ability to lead medical device development projects from early stage 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

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

Program Manager

Summary:

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

The Program Manager will be mainly responsible for managing and coordinating design and development of novel medical devices.

Responsibilities:

  • Manages and coordinates design and development of complex and novel Class II & Class III mechanical and electro-mechanical medical devices such as active implants and peripherals, surgical devices and external 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.

Requirements:

  • BS in a relevant engineering or science discipline with at least 5 years of experience within the medical device industry. Experience with neuromodulation devices, Implantable Pulse Generators (IPG’s) and/or implantable lead assemblies preferred but not required.
  • Demonstrated ability to lead medical device development projects from early stage 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

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

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Design & Development Quality Engineer

Summary:

Essential responsibilities of the Design & Development Quality Engineer are activities associated with Design Control and Design Quality Assurance during the Product Design and Development Process as well as continuation design & development support for sustaining manufacturing and product distribution. Additional general Quality duties and responsibilities include, but are not limited to: statistical qualitative and quantitative data analysis; returned product complaint investigation and analysis; Manufacturing Engineering support; Training and Education; Metrology and Gage R&R; and other Quality Management Systems functions as this role is expected to provide input and contribute on Quality System improvement strategies and approach.

Responsibilities:

  • Product / Process Development activities:
    • Author and execute Quality Plans for Product Design and Development projects.
    • Initiate and/or consult in the development and/or update of Risk Management FMEA and Hazard Analysis documentation in cooperation with cross-functional engineering teams per project requirements.
    • Develop and perform operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements.
    • Provide direction in implementing Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans.
    • Develop and justify appropriate sampling plans with characterization of test/inspection methods and acceptance criteria.
    • 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.
    • Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.
    • Represent Quality Engineering in design and phase reviews throughout the product development process.
  • Ensure FDA and ISO Compliance in all areas:
    • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NMR’s.
    • Provide statistical data / trending analysis on CAPA, NMR and other quality metrics.
    • Provide quality oversight on maintaining ISO Class 7 clean rooms including review and trending of the testing and monitoring reports
  • Strong verbal and written communication skills, including technical report writing
  • Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
  • Other duties as assigned.

Requirements:

Educational: 

  • Bachelor of Science Degree in Engineering, Manufacturing Design, Biomedical or related Technical discipline.
  • Advanced Degree preferred.

Technical: 

  • Minimum of 2-5 years of experience in a regulated manufacturing environment.
  • Experience managing/supervising other personnel preferred.
  • Experience with medical device design and manufacturing requirements, specifically in the areas of design control and design transfer for manufacturing/production.
  • Demonstrable knowledge and experience with Design Assurance tools/methodologies including: Design Controls, Design Change Assessment, Risk Management (Hazard Analysis), Design and Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.
  • DFx / DFm / DFr knowledge and experience preferred.
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDD, TGA, MHLW, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPAs and customer complaints.

Skills: 

  • Strong verbal and written English language communication skills, including experience in technical protocol and report writing.
  • Ability to work with cross-functional groups and teams including R&D, Manufacturing, and QA as required working collaboratively to accomplish results with minimal guidance.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.

Training: 

  • Training or equivalent work experience with general computer use and software applications (e.g. Microsoft Word, Excel, Power Point, Visio and Access).
  • Experience with statistical software tools (i.e. Minitab) experience preferred.
  • Must be able to drive and implement quality initiatives, interpret collected data, and present the data to multiple levels of management as part of continuous improvement / continuation engineering activities.

Performance: 

  • Interaction: Capability to present information in public speaking forums including, but not limited to, the ability to meet with external agencies and clients/customers, as required/desired.
  • Initiative: Capability to function independently without supervision.
  • Leadership: Capability to effectively lead and initiate discussions and meetings with Sr. Management staff and team.
  • Analytical Problem Solving: Capability to employ systematic and logical approached to problem-solving and develop and execute plans to take action/make adjustments.
  • Team Player: Must be able to work and thrive in a team environment.
  • Effective Communication: Excellent verbal and written communication skills and the capability to interface and communicate ideas, concepts, challenges and solutions with staff, cross-functional peers and personnel effectively.
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Design & Development Quality Engineer

Summary:

The position will be responsible for the activities associated with Quality Design & Development (QD&D) Control and Assurance during Product Development Process (PDP) activities as well as continuation design & development support for sustaining manufacturing and product distribution.

Responsibilities:

  • Design Input/ Output Characterization & Specification
  • Manufacturing Process Verification & validation Controls
  • Gage R&R, Test/Inspection Method Development & Qual.
  • Statistical Qualitative and Quantitative Data Analysis
  • Complaints Investigation/Returned Materials Analysis
  • Manufacturing Engineering support
  • Education & Training
  • ISO Class Controlled Environments
  • Metrology & Calibration (including Gage R&R)
  • Tracking and Trending Quality Objectives and Metrics,
  • Other Quality Management System Functions

This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.

Requirements:

Educational: 

  • Associate/Bachelor of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly-transferable industry work experience (Engineering or Quality discipline preferred).

Technical: 

  • Minimum of 2-5 years of experience in a regulated manufacturing environment.
  • Experience with medical device design and manufacturing requirements, specifically in the areas of design control and design transfer for manufacturing/production.
  • Demonstrable knowledge and experience with Design Assurance tools/methodologies including: Design Controls, Design Change Assessment, Risk Management (Hazard Analysis), Design and Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation.
  • DFx / DFm / DFr knowledge and experience preferred.
  • Knowledge and experience with external standards: ISO 9001, ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDD, TGA, MHLW, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPAs and customer complaints.

Skills: 

  • Strong verbal and written English language communication skills, including experience in technical protocol and report writing.
  • Ability to work with cross-functional groups and teams including R&D, Manufacturing, and QA as required working collaboratively to accomplish results with minimal guidance.
  • “Hands-on” self-starter with ability to work both independently and as part of a team.

Training: 

  • Training or equivalent work experience with general computer use and software applications (e.g. Microsoft Word, Excel, Power Point, Visio and Access).
  • Experience with statistical software tools (i.e. Minitab) experience preferred.
  • Must be able to drive and implement quality initiatives, interpret collected data, and present the data to multiple levels of management as part of continuous improvement / continuation engineering activities.

Performance: 

  • Interaction: Capability to present information in public speaking forums including, but not limited to, the ability to meet with external agencies and clients/customers, as required/desired.
  • Initiative: Capability to function independently without supervision.
  • Leadership: Capability to effectively lead and initiate discussions and meetings with Sr. Management staff and team.
  • Analytical Problem Solving: Capability to employ systematic and logical approached to problem-solving and develop and execute plans to take action/make adjustments.
  • Team Player: Must be able to work and thrive in a team environment.
  • Effective Communication: Excellent verbal and written communication skills and the capability to interface and communicate ideas, concepts, challenges and solutions with staff, cross-functional peers and personnel effectively.
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Swiss Machinist

Hours & Shifts:

  • 1st shift is Monday – Thursday from 5:00 AM – 3:30 PM
  • 2nd shift is Monday – Thursday from 3:30 PM – 2:00 AM
  • Weekend shift is Friday – Sunday from 6:00 AM – 6:30 PM

Summary:

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

Responsibilities:

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

Qualifications:

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

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.

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

Laser Technician

Summary:

This position is responsible for the safe and functional operation of laser cutting and welding equipment.  Will be responsible for developing manual or CAD programs required to cut or weld components.  Will assist in the development of tooling and fixtures required. To be self-motivated. Help lead the team in a manner to maximize production, Quality, and day-to-day functions.

Responsibilities:

  • Provide process training to production operators
  • Perform characterizations, IQ’s, OQ’s, PQ’s, and validations
  • Provide Laser samples when appropriate to support sales effort
  • Provide assistance to Engineering to develop laser quotations and manufacturing procedures
  • Develop CNC programming using a camming software to efficiently meet print requirements
  • Assist Engineering in designing tooling for production
  • Interface with Quality to develop inspection procedures to verify acceptability of components
  • Maintain and promote laser and team safety
  • Evaluate and recommend alternative manufacturing methods
  • Maintain and encourage other to maintain a clean and orderly work area
  • Research and recommend capital equipment for the yearly budget
  • Ensure laser maintenance program is 100% up to date
  • Provides leadership to the team and interrelates well with all areas of the company
  • Effectively resolves all problems that arise or seek assistance in a timely manner
  • Assists the Team Manager in developing highly skilled individuals to be high quality efficient operators
  • Performs duties in a manner to promote good department morale with the team
  • Trains team members and new employee on machines and department procedures
  • Maintains schedules of machines to best meet customer requirements based on meeting daily production schedule as supplied by M2M and Production Control
  • Demonstrates responsibility for department efficiency, quality, pre-production planning, process control, corrective actions, cleanliness and safety
  • Ensures that job BOM’s are accurate and tooling is ordered on timely manner

Qualifications:

  • Recent pulsed laser cutting experience
  • Experience with high tolerance cutting, welding and drilling of metals
  • Set up of laser parameters
  • Experience or a desire to learn CAD/CAM software
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Process Engineer Technician

Responsibilities:

  • Run equipment tests, collect data and analyze data with the engineering team
  • 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
  • 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. Software (Embedded) Engineer

Summary:

Based out of our headquarters in Brooklyn Park, MN, The Sr. Software (Embedded) Engineer will be mainly responsible for development and integration of embedded software for novel Class II and III medical devices.

Responsibilities:

  • Participate in software system architecture development and document software requirements and development plan
  • Perform detailed design analysis and reviews with hardware engineering team to achieve product performance, cost, reliability and manufacturability requirements
  • Track software related issues and lead resolution of issues with a well-documented and methodical approach
  • Develop software test and verification plans and protocols, and conduct prototype testing and verification testing
  • Work closely with hardware engineering team to debug/integrate software with hardware
  • Collaborate with program managers to create and manage development plans and project plans related to software development
  • Lead and contribute towards creation of software design history file, risk management documentation, issue tracking, configuration management, etc.
  • Develop and maintain relevant documentation (for e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files

Requirements:

  • Experience with microcontrollers (ARM, Texas Instruments), communication controllers (Zarlink, Bluetooth), IC interfaces (SPI,I2C), DSP
  • Extensive experience developing firmware solutions using C, C++, and Assembly (experience with event driven and state machines designs preferred)
  • Strong HW / SW bring-up and debugging skills
  • Capable of working independently in a hardware lab with oscilloscopes, signal generators, power supplies and other test equipment
  • Knowledge and understanding of IEC 60601 and IEC 62304 and other relevant medical device regulatory standards highly preferred but not mandatory
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
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 novel Class II and III medical devices.

Responsibilities:

  • Lead system architecture design, sub-system requirements partitioning, requirements management and configuration management during product development
  • Develop system requirements, technical specifications and development plans based on marketing and regulatory needs, and applicable standards
  • 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
  • Manage and lead resolution of systems engineering issues including systems architecture, hardware and software design trade-offs
  • Develop verification and test plans and protocols, and manage prototype testing and design verification testing
  • 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

Requirements:

  • BS in Electronics or Computer Engineering or in an equivalent engineering discipline. Advanced degrees preferred.
  • Experience with development of neuromodulation devices highly preferred.
  • Demonstrated expertise in systems engineering and requirements management
  • Working knowledge of medical device regulatory standards, for e.g. IEC 60601 and related standards
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Assembler I

Summary:

This position is primarily responsible to perform assembly operations according to written procedures in the clean room environment meeting all quality standards. Be familiar with and follow operating requirements including GMPs (Good Manufacturing Practices) and specific customer defined requirements.

Responsibilities:

  • Perform assembly operations per written procedures meeting both quality and productivity requirements.
  • Follow verbal and written instructions of Trainers, Supervisors and Engineers.
  • Active participation in improving quality and processes.
  • Demonstrate the ability to read blueprints, use microscope and inspect all print requirements of components affected
  • Communicate effectively when problems arise or efficiencies can’t be met by yourself or other team members.
  • Understand and promote good manufacturing practices (GMPs) including all clean room related requirements.
  • Interact effectively with engineering and quality to solve problems.
  • Show self-motivation to optimize job performance on a continual basis.
  • Demonstrate concern for equipment by proper use of it.
  • Maintain a clean and orderly work area.
  • Ability to diagnose and solve problems with jobs in a timely manner.
  • Other duties as assigned.

Requirements:

  • One year minimum of microscope experience
  • Attention to detail
  • Ability to interpret written and verbal work instructions
  • Blueprint reading

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

Process Engineer - Manufacturing

Summary:

Defines, develops, designs, and validates manufacturing processes, also performs modification of existing processes for medical device assemblies and components. Works within the engineering department suggesting areas for improvements positively impacting product quality, cost and delivery.

Responsibilities:

  • Creates and improves processes pertaining to:
    • Feasibility Builds, Manufacturing, and Inspection
    • Planning and executing process characterization activities, through tools i.e. design experiments
    • Equipment selection
    • Process development and documentation
    • Component validation and verification samples and testing
    • Develops and executes IQ, OQ and PQ protocols and reports
    • Operator training
    • Process Failure Mode Effects Analysis
    • Clinical Builds
    • Process Validation
    • Assembly and Component Process flow layouts
  • Involved with manufacturing and product design teams to:
    • Facilitate and create processes
    • Implement systems to produce a quality and cost effective product
    • Improve Labor cycle times
  • Improve existing processes for boosting productivity, quality and cost
  • Assist with the preparation of proposals and quotes for customers
  • Creates process risk assessments
  • Assesses safety requirements ensuring they are part of the process for the builder, user and customer
  • Prepares Engineering Change Orders for processes, components, and Bill of materials
  • Performs and advises Corrective and Preventive Action tasks
  • Other Duties as assigned

Requirements:

  • FDA cGMP principles and practices
  • Must have 3 or more years’ experience of medical device process or manufacturing engineering
  • Familiarity with biocompatible materials
  • Exposure to Pro-E / CREO and or SolidWorks preferred
  • Strong computer skills associated with Microsoft software
  • Demonstrated ability to interpret technical drawing, blueprints, specification and illustrations
  • Possess a keen attention to detail
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Demonstrated ability for systematic problem solving, DMAIC
  • Maintains performance with changing priorities under minimal supervision
  • Must maintain high ethical standards
  • Must be able to make clear and accurate decisions
  • Ability to learn and apply new technology
  • Must have a BS degree in relevant engineering discipline with a minimum 3 years of related engineering experience
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Sr. Process Engineer - R&D

Summary:

Defines, develops, designs, and validates manufacturing processes, also performs modification of existing processes for medical device assemblies and components. Works within the engineering department suggesting areas for improvements positively impacting product quality, cost and delivery.

Responsibilities:

  • Creates and improves processes pertaining to:
    • Feasibility Builds, Manufacturing, and Inspection
    • Process development and documentation
    • Clinical Builds
    • Process Validation
  • Planning and executing process characterization activities, through tools i.e. design of experiments
  • Develops and executes IQ, OQ and PQ protocols and reports
  • Operator training
  • Process Failure Mode Effects Analysis
  • Equipment selection and implementation
  • Design, develop, and implement fixturing to assist with medical device assembly
  • Qualify fixturing and manufacturing equipment
  • Assembly and Process flow layouts
  • Involved with manufacturing and product design teams to:
    • Facilitate and create processes
    • Implement systems to produce a quality and cost effective product
    • Improve Labor cycle times
  • Improve existing processes for boosting productivity, quality, and lowering cost
  • Assist with the preparation of proposals and quotes for customers
  • Creates process risk assessments
  • Assesses safety requirements ensuring they are part of the process for the builder, user, and customer
  • Prepares Engineering Change Orders for processes, components, Bill of materials, routings, fixturing, etc.
  • Performs and advises Corrective and Preventive Action tasks
  • Other Duties as assigned

Requirements:

  • FDA cGMP principles and practices
  • Must have 3 or more years’ experience of medical device process or manufacturing engineering
  • 2 years’ experience with bonding techniques. I.E. – Adhesives, Chemical, Laser, Resistance welding
  • Familiarity with biocompatible materials
  • Exposure to Pro-E / CREO and or SolidWorks preferred
  • Strong computer skills associated with Microsoft software
  • Demonstrated ability to interpret technical drawing, blueprints, specification and illustrations
  • Possess a keen attention to detail
  • Must be able to read, write and speak fluent English
  • Excellent reading, writing, communication, and organizational skills
  • Demonstrated ability for systematic problem solving, DMAIC
  • Maintains performance with changing priorities under minimal supervision
  • Must maintain high ethical standards
  • Must be able to make clear and accurate decisions
  • Ability to learn and apply new technology
  • Must have a BS degree in relevant engineering discipline with a minimum 3 years of related engineering experience
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Process Engineer - R&D

Responsibilities:

  • Attends and arranges project meetings to discuss current and future design and development initiatives.
  • 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
    • 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.

Requirements:

  • Willingness to travel, if required.
  • Must maintain high ethical standards
  • Must be able to read, write and speak fluent English.
  • A Bachelors degree in an engineering discipline and minimum 2 years appropriate work experience; or Associates degree in engineering discipline and a minimum or 4 years appropriate work experience; or a minimum 7 years relevant work experience; or equivalent.
  • Experience in an engineering/manufacturing environment with mechanical, tool design, and manufacturing processes preferred.
  • Strong computer skills, including the MS Office suite and MS Project.
  • Must be able to fully interpret technical drawings, blueprints, specifications & illustrations.
  • 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: 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

Senior Design Manager

Summary:

Based out of our division in Chandler, AZ, the Senior Design Manager will be mainly responsible for leading ASIC development teams through all phases of product development for low power portable devices including Class II and Class III medical ASICs.

Responsibilities:

  • Manage cross-functional ASIC development projects targeted for medical, sensing, and power management applications
  • Work closely with Program Management to provide the necessary resources and development tools to successfully bring products to market on-time, on-schedule and to specification
  • Provide technical guidance to design, product and test engineering teams and participate in design reviews
  • Proactively identify projects risks and issues, and guide engineering teams to formulate and implement risk mitigations and corrective/preventive actions
  • Collaborate with Program Managers to create and manage development plans related to ASIC development
  • Work closely with design team members and vendors to evaluate, recommend and setup CAD tools, lab equipment and technologies to bring products to market efficiently and successfully
  • Manage internal resources to meet goals and milestones on development programs, and identify additional resource needs to support business growth
  • Support Business Development team to engage new customers and maintain existing customer relationships
  • Support Business Development and Applications Engineering teams with definition of program scope, timeline, and budget to support preparation of quotations and change orders for customers
  • Leads continuous improvement of company’s ASIC design capabilities and technologies based on emerging industry trends
  • Provide career guidance, feedback, mentoring and support to the ASIC Design Team consisting of Analog, Digital and Mask designers
  • 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 Electrical or Computer Engineering or in an equivalent engineering discipline. Advanced degrees preferred.
  • 5+ years’ experience as an ASIC Design Engineer.
  • 5+ years’ experience as a Technical Design Lead or IC Design Manager
  • Experience with development of low power battery operated ASICs preferred
  • Experience in analog design preferred
  • Solid understanding of the ASIC Design flow from specification development to production release
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

Office Administrator

Summary:

This part-time position is primarily responsible for providing administrative support to our Chandler, AZ office. This position will play an integral role in the customer service and organizational strength of our company. Qualified candidates will have impeccable verbal and written communication skills, a strong ability to multi-task and a friendly demeanor. The office admin is responsible for various duties including greeting and checking in all visitors and deliveries, facilities maintenance, providing necessary support for daily meetings, ordering and stocking of office supplies. In addition, this role assists Accounting and HR as needed and provides general office support.

Responsibilities:

  • Monitor and maintain office equipment; inventory supplies and order replacement supplies as needed
  • Coordinate building and maintenance repairs with property manager
  • Perform light building and office maintenance such as replacing lightbulbs, setup and takedown of workstations, space planning and reorganizing
  • Shipping & Receiving- sort and distributes incoming mail and deliveries, prepares outgoing mail
  • Coordinate and facilitate customer and site visits- including ordering meals and the setup/cleanup of refreshments
  • Assist accounting– purchasing, matching and sorting of documents related to A/P and the input of documents into the ERP software
  • Keep office and coffee supplies stocked and orderly, order supplies as necessary
  • Organize conference rooms, oversee scheduling, equipment, and cleaning
  • Assist HR with event planning, coordinate on-site events
  • 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:

  • 2 years previous experience working in a fast-paced office setting
  • Associates degree preferred
  • Customer service oriented with a willingness to multi-task, performing a variety of duties and assist various functions in the organization
  • Excellent organizational skills, great follow through and ability to prioritize tasks
  • Ability to maintain confidentiality
  • Proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel); scheduling appointments/updating calendars a must
  • Excellent written and verbal communication skills
  • Ability to complete complex administrative tasks with minimal supervision
  • A proactive problem solver

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

Systems 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 division in Chandler, AZ, the Systems Engineer will be mainly responsible for system-level development and implementation of electronics and software designs for novel Class II and III medical devices.

Responsibilities:

  • Develop verification and test plans and protocols, and manage prototype testing and design verification testing
  • Develop calibration processes, for medical device RF communication systems such as the Microsemi ZL70103
  • Facilitates and coordinates development and implementation of electronic and software system designs with cross-functional engineering teams
  • Facilitates system architecture design, sub-system requirements partitioning, requirements management and configuration management during product development
  • 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
  • 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

Requirements:

  • BS in Electronics or Computer Engineering or in an equivalent engineering discipline. Advanced degrees preferred.
  • 5+ years’ experience as systems engineer or test engineer.
  • 2+ years working on medical device development
  • Experience with development of neuromodulation devices highly preferred.
  • Experience with the Microsemi ZL70103, TI MSP430, Arm Cortex M4 and/or TI MSP430 highly preferred
  • Demonstrated expertise in systems engineering and requirements management
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 50 pounds while moving equipment.  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 lab and/or 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 Enfield, CT

Tool Maker

Summary:

This position is primarily responsible for providing machine shop service including drilling, milling, turning, boring, reaming and general machining as required. Fabricate and maintain jigs, fixtures and prototype tooling from sketches, drawings and verbal information. Assist in maintaining model shop and provide maintenance to all shop equipment as necessary.

Responsibilities:

  • Provide general machining services to support all aspects of engineering, manufacturing, research and development or to support customer orders.
  • Assist in maintaining and organizing model shop and all related equipment to be as efficient as possible to meet engineering and manufacturing’s needs.
  • Manufacture tools, jigs and fixtures including prototype development and procurement.
  • Organize and maintain storage area for tools, raw stock, fasteners and measuring equipment.
  • Maintain, repair and refurbish in house tools, jigs and fixtures.
  • Recommend and specify upgrades on shop equipment as required.
  • Assist the engineers in the conceptualization of new fixtures.
  • Assist in the quotation process for new or modified fixtures.
  • 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:

  • Must be able to read, write and speak fluent English.
  • Technical training or equivalent experience in a tool machine/machine shop environment.
  • Must be familiar with and be able to operate, set up and maintain the following equipment: Bridgeport, Lathe, surface grinder, cut-off saw, inspection devices and related equipment.
  • Must be able to interpret technical drawings, blueprints, specifications and illustrations.
  • Must be familiar with various computer programs such as Word & Excel
  • In-house on the job and / or external training as required to meet job requirements.
  • Decision-making and Problem Solving: Must be able to make clear and accurate decisions.
  • Interaction: Must be able to communicate well, both verbally and in writing, and work well in a team environment.
  • Must be able to respond to changing priorities with minimum disruption.
  • Must be able to function with minimum supervision.

Physical Demands:

While performing the duties of this job, the employee is frequently required to sit, stand, walk, talk and/or hear. The use of your hands to handle or touch objects, tools, or controls will also be required. The employee must occasionally lift and/or move up to 45 pounds while in this position. 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

Sterilization Engineer

Summary:

This position is responsible for technical execution of activities associated with projects in the global sterilization network to improve operational efficiency, ensure predictable product flow, and enable lowest total cost of ownership.

Responsibilities:

  • Subject Matter Expert for in-house and external Ethylene-Oxide (EO) sterilization services.
  • Provide organizational technical support for in-house and external sterilization, maintaining flow of Design/Development programs and Sustained Manufacturing product lines.
  • Lead development, review and approval of load configurations, Process Challenge Devices, sterilization validations, and product family adoptions.
  • Support sterilization chamber equipment qualifications & equivalencies and routine re-qualification/re-validation activities.
  • Develop and optimize sterilization cycles with the intent of improving cycle times, reducing lead times, and improving internal operating costs.
  • Oversee routine bioburden and environmental monitoring programs and assessing residual impact to sterilization validation status.
  • Coordinate external testing for test method development, cycle validations and routine bioburden and environmental sampling.
  • Coordinate external verification testing for Biological Indicators.
  • Develop Standard Operating Procedures, Manufacturing Work Instructions, Test Methods and provide on-site training to applicable technical staff.
  • Establish preventive maintenance programs for sterilization, requalification, product loading, and material handling.
  • Develop and maintain knowledge of applicable industry standards and regulations for sterilization.
  • Assure compliance with Federal, State and local safety/environmental regulations. Assist in environmental testing and reporting.
  • 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:

  • Minimum 4-Year degree or equivalent of directly-transferrable industry work experience (Engineering or Biological discipline preferred).
  • Minimum of 3-5 years’ experience in a medical device sterility assurance, sterilization operations or testing environment.

Preferred Qualifications & Experience:

  • Advanced Post-Secondary Education/Training/Certification coursework
  • 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:
  • 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

Sr. Program Manager

Summary:

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

Responsibilities:

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

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

Qualifications:

  • Willingness to travel, if required.
  • Required to maintain high ethical standards
  • Must demonstrate good organizational skills.
  • 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 Bachelor’s degree in an engineering discipline with 5 years of applicable experience or equivalent.
  • Minimum 3 years in project engineering. Demonstrated ability to lead projects from early stage development to production.
  • Minimum 7 years’ 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.

 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:

  • 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.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Engineer

Summary:

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

Responsibilities:

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

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

Qualifications:

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

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

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Supply Chain Manager

Summary:

The Manager of Supply Chain is responsible for the management and execution of planning, purchasing, scheduling and materials management. The role drives continuous improvement in safety, reliability, cost, and personnel management. The Manager of Supply Chain will lead a team and contribute directly to the success of the Enfield facility and Cirtec Medical.

Responsibilities:

  • Develop plans to improve business processes related to Supply Chain management practices associated to planning, purchasing and materials management.
  • Purchase direct materials required for operations and drive cost improvement projects.
  • Establish, monitor and improve KPIs associated with supply chain functions such as schedule attainment, purchase price variance, inventory turns and accuracy, etc.
  • Hire, develop and manage the performance of a cross-discipline supply chain organization.
  • Manage cross-functional projects as assigned.
  • 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:

  • Bachelor’s degree preferred.
  • Demonstrated supply chain management and improvement experience.
  • Strong leadership, communication, and change management skills across multiple discipline of supply chain and operations.
  • Minimum of 5 years’ experience in contract and or medical device manufacturing with progressive management of personnel and team building.
  • A record of improving supply planning, capacity planning, inventory, and production planning.
  • Working knowledge and experience in Lean and Six Sigma methods, implementation of ERP and QMS systems, logistics and procurement processes, and warehouse management is required.
  • Experience with and managing with ISO 9001 and 13485 procedures preferred.

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

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Master Production Scheduler

Summary:

This position is primarily responsible for developing the master production plan to satisfy customer demand while carrying minimum effective inventory, providing the plant with a monthly production plan consistent with the plant capacity and sales forecast.

Responsibilities:

  • Create a rolling 3-month Master Production Plan for designated products.
  • Utilize the production capacity, taking into consideration the sales forecast, historical sales, and new business opportunities.
  • Analyze and identify risks associated with the options built into the Master Production Plan, including manufacturing lead times. Schedules emailed to the plants monthly.
  • Perform supply demand analysis each quarter, highlighting areas of concern for the next 12 months.
  • Make delivery commitments on MTO products, which involve checking uncommitted material and availability of capacity.
  • Develop inventory targets and manage production to achieve targeted inventory levels on both a cost and unit basis.
  • Maintain finished goods inventory at target levels in ensure high service levels, i.e. product availability.
  • Project finished goods inventory levels on a quarterly basis. Achieve desired corporate inventory turn targets.
  • Ensure coordination with plant schedulers to execute Production Plan on a weekly and monthly basis.
  • Monitor actual output versus the Master Production Plan. Identify gaps and drive solutions, including a metric on production performance to the requested production schedule.
  • Review sales forecast with business manager on a monthly basis and suggest modifications consistent with knowledge of current or historical demand.
  • Timely reporting of key metrics.
  • Support the S&OP process meetings to review service levels, performance against schedule, inventory strategy, supply plan to meet demand, and resource implications. Update Master Production Plan as necessary.
  • 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:

  • BA/BS degree Business Administration, Supply Chain Management, Logistics, Operation Research
  • Experience in managing manufacturing processes, productivity, and efficiency measurements
  • Experience using MRP / ERP systems, especially Advance Planning Systems
  • Strong Experience in M2M
  • APICS certification (CPIM or CSCP), 5 years in Master Scheduling and Inventory Control
  • Sound knowledge of supply chain processes and procedures including manufacturing planning, demand, and replenishment processes.
  • Strong negotiation skills with the ability to reason and influence at all levels.
  • Solid communication and presentation skills.
  • Robust problem solving and analysis 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

Quality Systems Engineer

Summary:

The position will be responsible for ensuring operational adherence and compliance to Cirtec Medical’s Quality Management System (QMS) requirements. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.

Responsibilities:

  • Corrective/Preventative Actions (CAPA):
    • Serves as Subject Matter Expert (SME) for the CAPA system.
    • Responsible for CAPA system administration, including conducting periodic meetings, tracking individual CAPAs, and, as necessary, performing work on individual CAPAs.
  • Complaints Investigation/Returned Materials Analysis:
    • Knowledge of process(es) for investigation/analysis of returned/complaint materials.
  • Nonconforming Material (NCM) Control:
    • Knowledge of ID, traceability, and containment requirements for handling of NCM.
    • Knowledge of Material Review Board (MRB) responsibilities and handling of NCM.
  • Supplier Quality Management:
    • Support supplier/vendor Qualification activities.
    • Support Management of the Approved Supplier/Vendor Listing (ASL/AVL).
    • Manage Supplier/vendor Corrective Actions (SCAR).
  • Internal Auditing:
    • Provide Support for the system to ensure all internal audits are performed as scheduled.
    • Perform internal audits to assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System, including investigation observations/findings and reporting.
  • Documentation Control:
    • Support local Document Control (PLM) and Material Resource Planning (MRP) systems.
  • Training and Education:
    • Ensure adherence to training requirements regarding Quality Management System elements, controls, processes and procedures.
  • Preventive Maintenance, Calibration & Metrology (Gage R&R):
    • Knowledge of selection and testing methodology to define and collect data to support accuracy, reliability, and capability for purpose of measurement and test equipment.
  • Author and execute Quality Plans for the QMS and Organizational Objectives projects.
  • Support Corporate Quality Management System initiatives and continuous improvement activities.
  • Provide support for the compliance of Quality System support elements (QM ‘feeder’ systems) for the site QMS and the tracking & reporting of associated metrics, as required.
  • Ensure compliance to regulatory standards and requirements as applicable.
  • Provide quality support on maintaining ISO Class clean rooms including review and trending of the testing and monitoring reports
  • Support site customer-requested auditing activities (Customer and Regulatory Agencies).
  • Ensure compliance of all site personnel to Corporate and site-level QMS and functional training requirements.
  • 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:

  • Associate/Bachelor of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly-transferrable industry work experience (Engineering or Quality discipline preferred).
  • Minimum of 2-5 years’ experience in a regulated manufacturing environment.
  • Technical training and/or experience in a related field.
  • Must be able to read, write and speak fluent English.
  • Knowledge and experience with external standards: ISO 9000/9001, ISO 13485, and 21CFR 820 (FDA cGMP/QSR).
  • Familiarity with Class II or Class III medical devices
  • Experience in use of computer systems specifically Microsoft Office, calibration and maintenance programs.
  • Strong verbal and written communication skills
  • Ability to work with a wide variety of functional areas, including but not limited to Program Management, R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.
  • Must be able to respond to changing priorities with minimum disruption.
  • Must possess organizational skills.
  • Ability to troubleshoot problems in a narrow time frame.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Quality Control Inspector-2nd 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.

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.
  • Other duties as assigned.

Qualifications:

  • Be able to read, write and speak fluent English.
  • High school diploma-GED.
  • Certificate/s of training related to this field of work (medical or quality assurance.
  • A minimum of 2 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.

 APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Opportunities in Los Gatos, CA

Sr. Electrical Engineer

Summary:

The Senior Electrical Engineer will be mainly responsible for design and development of electronic systems as part of novel Class II and III medical devices.

Responsibilities:

  • Develop and implement circuit designs, including circuits for analog input signal conditioning, embedded control, telemetry, inductive power coupling, power supplies, battery systems, power management and battery charging
  • Develop electronic system and sub-system requirements, and development plans
  • Perform detailed design and analysis to achieve product performance, cost, reliability, manufacturability requirements
  • Design and/or lead design of printed circuit assemblies and electromechanical assemblies, including prototype development, testing and troubleshooting
  • Collaborate with software engineering team to specify, test and verify embedded software and firmware in the system
  • Interface with and manage suppliers to fabricate prototype and final design components
  • Participate in architecture design, subsystem requirements partitioning, requirements management and configuration management during product development
  • Build, test, debug, and maintain configuration of prototype assemblies
  • Develop test plans and protocols, and execute prototype testing and formal design verification testing
  • Perform Failure Mode Effects Analysis and participate in creation of risk management documentation
  • Develop and maintain documentation for specifications, designs, test plans and reports for inclusion in medical product Design History Files
  • Create and release medical device manufacturing process instructions, bills of material, lot history travelers, and related documentation
  • Participate in the development of quality inspection and manufacturing process instructions for electronic assemblies

Qualifications:

  • BS in Electronics / Computer Engineering or in an equivalent engineering discipline
  • 10+ years of experience within the medical device industry or a highly regulated industry
  • Expert level skills in electronic circuit design and commercial product design experience in areas of Neuromodulation, Embedded Control Design, Battery System and Power Management Circuits, Real-time Signal Processing, Wireless Charging and Communication highly preferred.
  • Expertise in electronic design automation tools: e.g.: PCB design (Altium preferred), schematic capture, analog and digital circuit simulation, tolerance analysis.
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Manufacturing Engineering Manager

Summary:

Based out of our facility in Los Gatos, CA, the Manufacturing Engineering Manager will be mainly responsible for managing and supporting sustained production, and launch of new products into clinical and/or pilot production.

Responsibilities:

  • Develops and implements robust cost-effective manufacturing processes and improves product flow, assembly methods, and product quality and safety performance for both sustained and new products
  • Coordinates the design transfer of new products to production including establishing assembly time and yield targets, training needs and quality control
  • Provides support and supervision to direct reports for the timely completion of projects, improvement initiatives and key activities
  • Develops, tests and implements tools, fixtures and equipment required for manufacturing processes
  • Develops manufacturing process instructions, inspection plans and lot history travelers
  • Develops and maintains process risk management documentation (PFMEA) to identify potential risks, and implement preventive and corrective actions
  • Manages and/or supports equipment management, qualification and calibration
  • 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)
  • 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, and determines root cause and implements effective containment and countermeasures
  • Dispositions non-conforming products and develops required re-work procedures
  • Serve as Project Lead / Manager for sustained production projects and prepare periodic status reports for sustained production projects
  • 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
  • 10+ years of experience in manufacturing/process development, with 5+ years of technical staff management experience preferred
  • 5+ years of experience in medical device manufacturing
  • Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies
  • Solid knowledge of GMP and ISO regulations
  • Demonstrated success in leading and managing people in a team-based environment
  • Must be proficient in Solidworks and must be able to interpret technical drawings and specifications
  • 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
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Electrical Engineering Manager

Summary:

Based out of our Los Gatos, CA office, the Electrical Engineering Manager will be responsible for leading the architecture design, development and execution of electronic sub-systems for Class II/III medical device development programs. You will be an integral member of our product development team and will be responsible for providing leadership to our team of highly skilled Electrical Engineers.

Responsibilities:

  • Lead, and serve as high-level individual contributor in, development and implementation of electronic system designs
  • Lead and grow a team of highly skilled electrical engineers, and provide guidance and mentorship to direct reports
  • Lead creation of architecture design, system requirements and design specifications
  • Determine applicable regulatory standards and guidance clauses and ensure appropriate integration into system design requirements
  • Collaborate with program management to create and manage development plans and project plans related to electronic system development
  • Perform detailed analysis and oversee work of electrical engineers to achieve desired product performance and to meet cost, reliability and manufacturability requirements
  • Communicate directly with customers to understand project / product needs, and present technical updates, risks and issues
  • Lead and participate in design of printed circuit assemblies and electromechanical assemblies, including prototype development, testing and troubleshooting
  • Collaborate with software engineering team to specify, implement and verify embedded software and firmware
  • Develop verification and test plans and protocols, and manage prototype testing and design verification testing
  • 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

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 or advanced degree in Electrical Engineering or an equivalent engineering discipline
  • 10+ years’ experience developing medical devices and 5+ years’ experience leading and/or managing engineering teams
  • Experience with development of neuromodulation devices highly preferred.
  • Demonstrated expertise in electronic design, schematic capture and PCB layout tools (Altium strongly preferred)
  • Experience and demonstrated expertise in formal systems engineering methodologies (e.g.: requirements management)
  • Familiarity with medical device regulatory standards, for e.g. IEC 60601 and related standards
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral

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

Protective Clothing Required: 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 Lowell, MA

Human Resources Manager

Summary:

This position is responsible for develops policy, directing and coordinating human resources activities, such as: employment, compensation, labor relations, benefits, training, and employee services by performing the following duties.

Responsibilities:

  • Analyzes wage and salary reports and data to determine competitive compensation plan.
  • Writes directives advising department managers of Company policy regarding equal employment opportunities, compensation, and employee benefits.
  • Consults legal counsel to ensure that policies comply with federal and state law.
  • Develops and maintains a human resources system that meets top management information needs.
  • Oversees the analysis, maintenance, and communication of records required by law or local governing bodies, or other departments in the organization.
  • Identifies legal requirements and government reporting regulations affecting human resources functions and ensures policies, procedures, and reporting are in compliance. Studies legislation, arbitration decisions, and collective bargaining contracts to assess industry trends.
  • Writes and delivers presentations to corporate officers or government officials regarding human resources policies and practices.
  • Recruits, interviews, tests, and selects employees to fill vacant positions.
  • Plans and conducts new employee orientation to foster positive attitude toward Company goals.
  • Keeps records of benefits plans participation such as insurance and pension plan, personnel transactions such as hires, promotions, transfers, performance reviews, and terminations, and employee statistics for government reporting.
  • Coordinates management training in interviewing, hiring, terminations, promotions, performance review, safety, and sexual harassment.
  • Advises management in appropriate resolution of employee relations issues.
  • Responds to inquiries regarding policies, procedures, and programs.
  • Administers performance review program to ensure effectiveness, compliance, and equity within organization. Administers salary administration program to ensure compliance and equity within organization.
  • Administers benefits programs such as life, health, and dental insurance, pension plans, vacation, sick leave, leave of absence, and employee assistance.
  • Investigates accidents and prepares reports for insurance carrier. Coordinates Safety Committee meetings and acts as Safety Director.
  • Conducts wage surveys within labor market to determine competitive wage rate.
  • Prepares budget of human resources operations.
  • Prepares employee separation notices and related documentation, and conducts exit interviews to determine reasons behind separations.
  • Prepares reports and recommends procedures to reduce absenteeism and turnover.
  • Represents organization at personnel-related hearings and investigations.
  • Contracts with outside suppliers to provide employee services, such as temporary employees, search firms, or relocation services.
  • 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:

  • Bachelor’s degree.
  • 7-10 years’ prior human resources management experience.
  • Ability to read, analyze, and interpret the most complex documents.
  • Capability to respond effectively to the most sensitive inquiries or complaints.
  • Ability to write speeches and articles using original or innovative techniques or style.
  • Capacity to make effective and persuasive speeches and presentations on controversial or complex topics to top management.

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

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
  • Perform legal and factual research, along with records research.
  • 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:

  • 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.

APPLY NOW  – or email CareersAtCirtec@Cirtecmed.com

IT Support Specialist

Summary:

This position is primarily responsible in providing day-to-day technical support to employees for network infrastructure and internal desktop systems software and hardware. Install, configure and troubleshoot desktop systems, workstations, servers and network issues in a mixed Windows environment. Maintain passwords, data integrity and file system security for the desktop environment. Communicate highly technical information to both technical and nontechnical personnel. Recommend hardware and software solutions, including new acquisitions and upgrades. Participate in development of information technology and infrastructure projects. Conduct training programs designed to educate an organization’s computer users about basic and specialized applications.

Provide support for and maintain telephone system and all other communication media, including video conferencing.

Responsibilities:

  • Support and provide ongoing maintenance to existing Microsoft Windows desktop environment.
  • Troubleshoot and resolve desktop user issues in Microsoft Windows environment including Microsoft Office and related software.
  • Maintain Microsoft Active Directory user profiles and group memberships.
  • Make recommendation to resolve hardware and software issues on enterprise level.
  • Maintain and comply with software license agreements and maintenance.
  • Maintain Microsoft Servers and apply updates/upgrades accordingly.
  • Follow and support in-place IT department protocol and management process.
  • Timely management of daily IT operations and deliverables.
  • Adhere to proper procedures and produce documentation required for validation.
  • Operations: Administer operations applications, e.g., backups, system monitoring, logging. Initiate action to ensure problems and potential error conditions are promptly and appropriately addressed.
  • Network: Maintain site network infrastructure to ensure performance and reliability for local LANs, Internet, and corporate WAN connectivity.
  • Communication: Ensure ongoing communications regarding issues and activities relating to systems operations with IT Management.
  • Equipment: Maintain computer hardware; ensure cleanliness and organization in equipment rooms; verify all equipment and cabling is properly installed for safety, reliability and neatness.
  • Effectively manage data backups to ensure easy recovery from any disaster and adhere to 3-2-1 backup rule. 3 copies, on 2 different types of media and 1 off site.
  • Manage local vendors and or contractors to help supplement IT projects, infrastructure, coverage and technical support.
  • 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:

  • High School Diploma.
  • College or Technical School Degree or equivalent experience.
  • 3-5 years Desktop/Network/Server Support and Administration.
  • Microsoft certification for desktop support or equivalent experience.

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

Materials Coordinator

Summary:

This position is primarily responsible for inventory control, order entry, creation of shipping documentation, job closings, and inventory reconciliation. Will be required to work closely with the following departments: Production, Finance, Purchasing providing general office support

Responsibilities:

  • Review jobs requiring materials via the ERP system
  • Enters new orders, processes change orders and RMAs in M2M.
  • Issue materials to assigned jobs physically and in ERP system
  • Return materials from completed jobs physically and in ERP system
  • Perform monthly cycle count in assigned area(s)
  • Communicate any material shortages to appropriate departments as needed
  • Prepare outgoing shipments to subcontract suppliers
  • Close all production jobs, verifying material issues before doing so.
  • Copy all documents necessary for and file into the DHR file.
  • Prepare shipping documentation in support of AR invoicing.
  • Provide customers with Inventory reports of their material as requested.
  • Create “customer supplied” materials purchase orders
  • Support customer service with releasing job orders to the floor.
  • Maintain and monitor manual or computerized inventory control system for raw materials and finished stock.
  • Investigate all discrepancies.
  • Perform cycle counts and assist with annual physical inventory as required.
  • Support or provide back-up to Shipping, Production and Inventory Control functions as required.
  • Respond to customer inquiries regarding invoices and proof of delivery as well as inventory reports for materials
  • Complete shipping and invoicing processes
  • Process credits/rebills, EDI, collections and invoicing issues.
  • Manage process for completing NDAs and supplier surveys.
  • Order and maintain office and printer supplies as needed.
  • Answers incoming telephone calls- directing to appropriate individuals, or taking messages as required, in addition to meeting/greeting guests as needed.
  • 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 2 years previous experience working a front desk in a fast paced environment.
  • High School level education, with good customer service and communication skills (both written and oral).
  • Excellent organizational skills and great follow through.
  • Ability to maintain confidentiality.
  • Willingness to multi-task, performing a variety of duties and assist various functions in the organization.
  • A proactive problem solver.
  • Minimum five years’ experience in a manufacturing environment, two years of which include operation of an automated inventory control system, a plus.
  • Inventory management and control disciplines
APPLY NOW – or email CareersAtCirtec@Cirtecmed.com

Equipment Maintenance Technician

Summary:

Responsible for performing all preventive and corrective maintenance on equipment located in the fab and plating areas. It is expected that the equipment maintenance technician works independently and is capable of being successful in a matrix organization.

Responsibilities:

  • Responsible for preventive and corrective maintenance on all fab / plating area tool sets, including component disassembly / assembly / repair
  • Responsible for identifying needed parts for repairs / preventive maintenance
  • Properly handle and store chemicals and hazardous waste
  • Maintain written logs of maintenance and repairs in our online system
  • Perform other duties as assigned by your supervisor

Requirements:

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