Design Quality Engineer - Medical Devices

Job ID: 615073

Our 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 the area or planning to relocate to Connecticut***

Top 3 Skills Needed:

1. Design Failure Modes and Effects Analysis Development
2. Critical to Quality and Critical to Function understanding from Design, Part, Component, Assembly Perspective
3. Reliability Test Method Development / Strategy / Statistical Analysis

Responsibilities:

• 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.
• conducting dFMEA; CTQ Analysis; Design Failure Mode Effective Analysis; develop CTQs; develop DFMEA
• 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 Crtiical to Quality CTQ Component / Part Feature Criticality Development Engineering Testing/Development Design Verification and Validation Risk Based Design Verification and Validation Risk Management Understanding.

Requirements:

Bachelor's Degree with 3+ years of experience