Job Title: Design Quality Engineer
Job Location: Lexington, MA
Pay rate: Open
- The Design Quality Engineer will provide technical quality leadership and support for client’s medical device and combination product development efforts throughout clinical development, product registration, and commercialization.
- This DQE will support class 2 electromechanical and reconstitution devices, and other drug delivery devices as required.
- This DQE team member will work collaboratively with internal and external partners, on efforts such as design inputs, quality planning, risk management, design verification and validation testing, design transfer, and design changes.
- This DQE team member will ensure client’s develops medical devices and combination products in accordance with FDA 21 CFR requirements and international standards (e.g., ISO, AAMI, ANSI).
- Work cross-functionally to provide product quality requirements and quality standards into design inputs, to develop product specifications, and to conduct design verification and validation activities. Develop risk-based sampling plans for design verification and validation testing. Lead risk management and quality planning activities. Partner with and provide oversight of external design/development and manufacturing partners on development activities. Lead design control gap assessments and remediation as required.
- Partner with QA and CMC teams to provide technical quality support to root cause investigations, change control impact assessments, and risk management activities throughout product lifecycle.
- Ensure compliance to 21 CFR Parts 4 and 820, ISO13485, ISO14971, and other relevant international standards.
Education and Experience Requirements
- BS in engineering or equivalent technical discipline required, and advanced degreepreferred
- 3+ years of device and/or combination product development within a medical device or biotech / pharmaceutical organization required, including minimum of 1 in design quality, required
- Extensive knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 820, ISO13485, ISO14971), as well as other applicable standards required
- Experience in leading design quality activities required
- Experience with statistical and six sigma methods required, and Green/Black Beltpreferred
- Experience with risk management processes and tools required
- Experience with sustaining engineeringpreferred
- Experience with electromechanical device development required
- Experienceworking with external contract partners for design, development, manufacturing, and/or testing required
- Ability to travel within the US and internationally 10% requiredy