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

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Manufacturing Engineer

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