Manufacturing Engineer

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