What are the responsibilities and job description for the Sr. Development Quality Engineer position at ProKatchers LLC?
Job Title: Sr. Development Quality Engineer
Location: Westford, MA 01886 (Local candidates only.)
Duration: 12 months
Job Description:
- 2–5 years of experience supporting medical device product development.
- Experience in supporting class II medical devices.
- Experience with risk management, design control deliverables, risk assessments, and FMEAs throughout product development.
- Expertise in test method development, validation, and execution of design verification and validation activities.
- Strong working knowledge of FDA, EU MDR, and medical device quality system requirements, including audits and compliance activities.
- Experience working with Agile Software Development.