This is a core Manufacturing Engineer role focused on developing, optimizing, and validating production processes for medical devices within a regulated environment. The engineer will be instrumental in ensuring efficiency, quality, and regulatory compliance across all manufacturing operations.
Key Responsibilities:
- Lead and manage manufacturing improvement projects from concept through implementation.
- Drive continuous improvement initiatives across the production floor using methodologies such as Lean, Six Sigma, Kaizen, Kanban, and 5S.
- Develop and execute formal equipment and process validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Establish and maintain robust quality documentation, including PFMEAs, DFMEAs, Risk Assessments, and Control Plans.
- Analyze and interpret technical specifications, ensuring compliance through expertise in GD&T (ASME Y14.5M) and the interpretation of CMM reports.
- Execute measurement systems analysis (Gage R&R, TMVs) to ensure accurate quality data.
Qualifications
- Bachelor's degree in Engineering, Biomedical, or similar
- At least 2 years of engineering experience in a highly regulated environment
- Will look at more senior-level engineers as well
- Experience with Lean, Six Sigma, Kaizen, Kanban and 5S
Experience with one of the below is a big time plus!
- Metal finishing
- Any Casting experience
- Wax or Plastic Injection Molding
- CNC Machining (of Castings a bonus)
- Foundry Experience