Description
The Engineer I provides product and process engineering support throughout the medical device product lifecycle, with a primary focus on maintaining Risk Management Files and compliance with GTP/GMP/GLP and ISO 14971. The role leads root-cause investigations, engineering change requests, verification and validation testing, supplier qualification, technical documentation, audits, and continuous improvement initiatives while collaborating with cross-functional teams. It requires a bachelor’s degree in biomedical, biotechnology, chemical, or related engineering and at least one year of relevant experience in the medical device, biotechnology, or pharmaceutical sector.
