Responsible for managing product configuration and engineering documentation throughout the lifecycle of complex multidisciplinary medical devices (Mechanical, HW SW).
Key Responsibilities:
- Lead and manage Engineering Change Orders (ECO) processes.
- Maintain complex, multi-level BOMs (1,000+ items) using ENOVIA PLM.
- Manage product configurations, revisions, and part numbering.
- Control engineering, manufacturing, service, and production documentation.
- Ensure accurate product labeling in compliance with UDI and regulatory requirements.
- Collaborate with R D, Operations, Quality, Service, and Regulatory teams.
- Ensure compliance with ISO 13485, FDA, and MDR requirements.
Requirements: Bachelor's degree in Engineering (Mechanical, Electrical, Systems, Industrial, Bio-Medical is preferred) or a related technical discipline.
5+ years of experience in Documentation/Configuration Engineering within the medical device industry.
Hands-on experience with ENOVIA PLM, BOM management, and ECO processes.
Proven experience managing complex multidisciplinary BOMs (1,000+ items).
Strong knowledge of engineering documentation, DMR, DHF, and change control processes.
Understanding of ISO 13485, FDA QSR, and medical device labeling requirements (UDI).
Excellent communication skills and ability to work cross-functionally and manage multiple projects.
This position is open to all candidates.