Sr Quality Design Engineer Location: San Mateo, CA Duration: Full time Job Description:
Minimum of three years of experience in a design assurance role supporting medical devices that are FDA Class II or Class III.
Working knowledge of FDA design control deliverables (21 CFR 820), IEC 62304, AAMI TIR45, ISO 14971, and Cybersecurity.
Working knowledge of Agile Software Development methodologies and associated development tools (e.g. Jira, Jama).
Familiarity with the role of Human Factors/Usability in the software development lifecycle. ASQ (e.g. CQE, CRE, or CSQE) certifications or other software quality certificates are desirable.
Experience with supporting regulatory audits and FDA inspections is a plus.
Excellent interpersonal, verbal, and written communication skills.