Sr Medical Device Quality Engineer

2 days ago


North Haven, United States Grove Technical Resources, INC Full time

Job Title - Sr Medical Device Quality Engineer

Job Location - North Haven, Connecticut(Fully Onsite)

Type: W2 contract


Job Description:

The Senior Quality Engineer position on the team supports new product development for various product families in the Surgical Innovations Business. In this role, the Quality Engineer works as part of the quality team supporting the cross-functional core team. An understanding of Conducting/Leading/Developing the Design Failure Modes and Effects Analysis, the Critical to Function Matrix, Risk Management process per ISO 14971, Design Verification Protocol and Report Development and Review, Design Validation Protocol Development and Review, Reliability Test Method Development/Setup/Analysis, Develop/Conduct Reliability studies and evaluations, Mechanical and Electro-Mechanical Design, Reliability Test Development, Electromagnetic Compatibility (EMC) Requirements/Testing/Development. As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.


Must Have:

2-5 Years Experience in Quality with BS in Engineering

Bachelor’s degree in engineering, Science or Technical field with 4+ years of experience in Quality and/or Engineering OR Advanced Degree in Engineering, Science or Technical field with 2+ years of experience in Quality and/or Engineering

Conducting dFMEA

CTQ Analysis

Design Failure Mode Effective Analysis

Develop CTQs

Develop DFMEA

monitoring of CTQ parameters and specifications


Technical skills that are required for the role:

Design Failure Modes and Effects Analysis Development

Critical to Quality and Critical to Function understanding from Design, Part, Component, Assembly Perspective

Reliability Test Method Development / Strategy / Statistical Analysis


Responsibilities may include the following and other duties may be assigned.

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.

Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.


May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Leads the Development, Facilitation, and Collaboration of Deliverables such as DFMEA (Design Failure Modes Analysis), Critical to Quality (CTQ), Component / Part Feature Criticality Development, Engineering Testing/Development, Design Verification and Validation, Risk Based Design Verification and Validation, Risk Management Understanding.


  • Quality Engineer

    3 weeks ago


    North Haven, United States Tek Support Full time

    Job Description:Contribute to continuous improvements in overall product cost and quality.Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration.Collaborate with Quality Engineering to provide manufacturing support.Create standardized work and process maps that result in an optimized...

  • Quality Engineer

    2 weeks ago


    North Haven, United States Tek Support Full time

    Job Description:Contribute to continuous improvements in overall product cost and quality.Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration.Collaborate with Quality Engineering to provide manufacturing support.Create standardized work and process maps that result in an optimized...


  • North Haven, United States Planet Pharma Full time

    Job ID: 615073Our client, a leading Medical Device company, is seeking an experienced Quality Engineer for their growing team - this role is more geared towards design quality and reliability/FMEA (and not within manufacturing). See below for other details!***Please Note: This is a hybrid onsite role in North Haven, CT - only apply if you are either local to...

  • Quality Engineer

    1 month ago


    North Haven, United States Grove Technical Resources, INC Full time

    Job Title - Quality Engineer II - Exempt Job Location -North Haven, Connecticut.Duration: 06 Months Job Description - Support the work from the test team which entails prioritizing, reviewing, and providing feedback and direction on test plans and reports. Providing guidance on appropriate testing methods, sample sizes, and acceptance criteria, and then...

  • Quality Engineer

    1 month ago


    North Haven, United States Grove Technical Resources, INC Full time

    Job Title - Quality Engineer II - Exempt Job Location -North Haven, Connecticut.Duration: 06 Months Job Description - Support the work from the test team which entails prioritizing, reviewing, and providing feedback and direction on test plans and reports. Providing guidance on appropriate testing methods, sample sizes, and acceptance criteria, and then...


  • North Haven, United States Planet Pharma Full time

    Job ID: 615227Our client, a leading Medical Device company, is seeking a mid/senior level Process/Reliability Engineer who is able to work onsite at their North Haven, CT location (onsite 3x/week, home based 2 days). See below for other details!Summary:The Reliability Engineer will assume the role of Process Manager and be responsible for overseeing and...


  • North Haven, United States Redbock - an NES Fircroft company Full time

    NO C2C! W2 Candidates OnlySr. Quality Engineer (12 month contract // North Haven, CT):Hybrid/Flex: Minimum 3days / week In Office, 2 Days RemoteMay require some off hours work to coordinate with London siteTop 3 Skills:Design Failure Modes and Effects Analysis DevelopmentCritical to Quality and Critical to Function understanding from Design, Part, Component,...


  • North Haven, United States Sira Consulting, an Inc 5000 company Full time

    Responsibilities: - Develop and execute validation and verification protocols (IQ, OQ, PQ) to ensure processes and products meet specified requirements. - Prepare and maintain documentation required for regulatory submissions and audits, such as Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR). Experience: - Medical...


  • North Haven, United States ATR International Full time

    Job Title: Engineering Test Technician (Medical Device)Type: Contract - 12 Months*****NIGHT SHIFT****Location: 195 McDermott Rd, North Haven, CTPay: $32.00/hrWe are seeking a Test Technician I for a very important client. The Client is engaged in medical technology. A new product development team for the Surgical Innovation business in Client's Minimally...


  • North Haven, United States ATR International Full time

    Job Title: Engineering Test Technician (Medical Device)Type: Contract - 12 Months*****NIGHT SHIFT****Location: 195 McDermott Rd, North Haven, CTPay: $32.00/hrWe are seeking a Test Technician I for a very important client. The Client is engaged in medical technology. A new product development team for the Surgical Innovation business in Client's Minimally...


  • North Haven, United States ATR International Full time

    Job DescriptionJob DescriptionJob Title: Engineering Test Technician (Medical Device)Type: Contract - 12 Months*****NIGHT SHIFT****Location: 195 McDermott Rd, North Haven, CTPay: $32.00/hr We are seeking a Test Technician I for a very important client. The Client is engaged in medical technology. A new product development team for the Surgical Innovation...


  • North Haven, United States Planet Pharma Full time

    Job ID: 615073***Please Note: This is a hybrid onsite role in North Haven, CT - only apply if you are either local to the area or planning to relocate to Connecticut***Our client, a leading Medical Device company, is seeking an experienced Quality Engineer for their growing team - This group supports new product development – products in pipeline/R&D...

  • Quality Engineer

    1 week ago


    North Haven, United States I3 INFOTEK INC Full time

    Responsibilities: Contribute to continuous improvements in overall product cost and quality.Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration.Collaborate with Quality Engineering to provide manufacturing support.Create standardized work and process maps that result in an optimized...

  • Quality Engineer

    1 week ago


    North Haven, United States I3 INFOTEK INC Full time

    Responsibilities: Contribute to continuous improvements in overall product cost and quality.Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration.Collaborate with Quality Engineering to provide manufacturing support.Create standardized work and process maps that result in an optimized...


  • North Chicago, Illinois, United States Collins Consulting Full time

    Job Title: Medical Device EngineerThis is a hybrid position in North Chicago as lab work is required to be onsite.Description - Engineer IIIThe Contractor Engineer Combination Products works under technical supervision on project teams in support of combination products and medical devices. Activities include contributing to manufacturing transfers and...


  • North Haven, United States Grove Technical Resources, INC Full time

    Job Title: Medical Device Controls and Automation EngineerJob Location - North Haven, Connecticut(Fully Onsite)Type: W2 contractPosition Overview:We are seeking an experienced Controls and Automation Engineer with significant expertise in electrical controls, automation design, and programming. This role will be instrumental in supporting the manufacturing...


  • North Haven, United States Grove Technical Resources, INC Full time

    Job Title: Medical Device Controls and Automation EngineerJob Location - North Haven, Connecticut(Fully Onsite)Type: W2 contractPosition Overview:We are seeking an experienced Controls and Automation Engineer with significant expertise in electrical controls, automation design, and programming. This role will be instrumental in supporting the manufacturing...


  • New Haven, United States Nesco Resource Full time

    ONSITE 3 DAYS PER WEEK, NEW HAVEN, PARKING REIMBURSED Participate in the Human Factors / Usability Engineering for pipeline combination products as well as lifecycle managementThis position will manage the human factors deliverables, overall user interface evaluation, study design, development of labeling, integration of user needs, use risk analysis and HF...


  • New Haven, United States Nesco Resource Full time

    ONSITE 3 DAYS PER WEEK, NEW HAVEN, PARKING REIMBURSED Participate in the Human Factors / Usability Engineering for pipeline combination products as well as lifecycle managementThis position will manage the human factors deliverables, overall user interface evaluation, study design, development of labeling, integration of user needs, use risk analysis and...

  • Sr Quality Engineer

    3 weeks ago


    North Haven, United States Entegee Full time

    Job DescriptionJob DescriptionSummary:Senior Quality Engineer responsible for supporting new product development within the Surgical Innovations Business, focusing on risk management, reliability testing, and quality assurance.Job Requirements:BS in Engineering (EE preferred)4+ years of experience in engineering or quality rolesExperience with Risk...