Engineer: Injection Molding Engineer
Location
Cambridge, MA
Level
Full-Time
Department
Biotechnology
Type
Salary
Job Description
Posted on:
2025-04-15
Responsibilities
- Collaborate with team members to enhance injection molded products and processing.
- Develop and implement validation protocols (IQ/OQ/PQ) in compliance with FDA regulations.
- Provide troubleshooting support and conduct root cause analysis.
- Utilize Lean principles for technical solutions.
- Debug, package, and sterilize products.
- Document process changes using a change management system.
- Participate in cross-functional teams to improve safety, quality, and productivity.
Job Requirements
- B.S. in Engineering (Plastics or Mechanical preferred).
- Six Sigma Black Belt preferred.
- 7+ years of experience in molding, micromolding, and tooling.
- Experience in design improvements and SolidWorks/CAD.
- 7+ years in diverse technical, materials, and product design.
- Experience in statistical analysis and process control.
- Recent experience in medical device development in an FDA regulated environment.
