Back to jobsResponsible for the development/refinement of production processes and equipment; development and execution of process validations (Installation, Operational, & Process Qualifications) with sound engineering practices, and within company policy and regulations of FDA, and other regulatory bodies. The Senior Engineer utilizes a wide range of engineering principles, theories, and concepts in the manufacturing/mechanical engineering discipline, plus a working knowledge of related disciplines to solve a wide range of difficult problems with imaginative and practical approaches.
Provides training and guidance to lower-level Manufacturing Engineering personnel. Guidance may be technical, or project related as Project Leader or Lead Engineer of small to medium projects
Support efforts for complaint investigation compliance with the Food and Drug Administration (FDA), European Union Medical Device Directive (MDD), European Union Medical Device Reporting (EUMDR), Alternate Summary Report (ASR), and applicable regulations and regulatory governing standards.
Ensure timely and accurate investigations of returned products to support effective complaint closures as required by Complaint Engineering group.
Supports the FDA and other 3rd party audits as required by Complaint Engineering group.
Lead and execute design changes applicable to Manufacturing Engineering needs
Assess and Implement solutions relating to Corrective and Preventative Actions, Calibration Out of Tolerance Calibrations, Non-conformances.
