Responsible for performing all system Engineer activities including Product Management and Engineering activities as part of the Design Development Department. The position reports to the R D Manager.
Requirements: Develop and manage system -level requirements, traceability, and verification/validation (V V) plans and testing for a multidisciplinary medical device
Collaborate with cross-functional teams (Research Technology, Quality, Regulatory, Operations) to ensure system design meets clinical, user, and regulatory needs
Lead system integration and troubleshooting activities throughout the product lifecycle
Ensure system design complies with relevant regulatory requirements (FDA, ISO, IEC)
Manage Design History File (DHF) creation and update
Manage design reviews and post-market surveillance activities
Develop and maintain system engineering ation in alignment with QMS processes
Take part in QA activities such as: MRB, CAPA, risk management (per ISO 14971), including FMEA and hazard analysis
This position is open to all candidates.