Senior Quality Design Assurance Engineer - 6 Month Term
Core
Senior Quality Design Assurance Engineer supporting cross-functional teams in new product development and sustaining engineering to ensure compliance with design controls, regulatory requirements, and production processes for a 6-month term.
Role type
Senior IC Quality Design Assurance Engineer
Builds
Medical device technical documentation including requirements, verification, validation, risk management, and design change controls
Domain
Medical device industry, neuromodulation, regulatory compliance
Required skills
Design Assurance, FMEA, Risk Management, Statistical Analysis, Regulatory Compliance (ISO 13485, ISO 14971, 21 CFR 820), Design Verification/Validation, Technical Documentation Review
Preferred skills
Firmware Design Assurance, Software Design Assurance, Medical Device Cybersecurity
Technologies
ISO 13485, ISO 14971, 21 CFR 820, FMEA
Responsibilities
Identify and implement effective design controls; Mentor cross-functional teams on design control and risk management; Complete risk analysis studies using FMEA; Review and approve design verification test plans, protocols, and reports; Develop test method validation requirements; Utilize statistical analysis for product reliability and process capabilities; Support design change control and DHF documentation updates.
Seniority
Senior, hands-on IC
