Sr Manufacturing Engineer
880 Technology Park Drive Billerica, MA 01821 US
Job Description
Top 3 technical skills that are required for the role:
- Evaluate, develop, validate and implement manufacturing processes and process improvements for Medical devices or regulated industries
- Problem solving, root cause investigation, experience with CAPA
- understanding of lean manufacturing and six sigma tools
Education Required:
- Bachelor of Science Degree in Mechanical Engineering, Packaging Science, or similar discipline.
Years’ Experience Required:
- Minimum of 5 years in medical device or pharmaceutical industry in Manufacturing Engineering, Packaging or Quality Engineering.
- Requires practical knowledge and demonstrated competence within manufacturing engineering, process development, packaging engineering typically obtained through advanced education combined with experience.
- Knowledge and working experience of Lean manufacturing and six sigma practices
- Knowledge and general understanding of ISO 11607 part 2, ASTM and ISTA package test methods is preferred
The Manufacturing Engineer will lead and support various process improvement and remediation activities. Activities to include but not limited to the following.
- Fixture design, procurement, installation, validation
- Process map, process development, time studies, line layouts
- Labeling system set-up, system updates, documentation updates
- Process validation IQ/OQ/PQ
- Author, update, and execute engineering Protocols and closing Reports
- Documentation PLM system updates (BOM, SOP, visual aids, drawings, Work instructions)
- Conduct and support Root Cause Analysis, Measurement System Analysis, gemba walks, update PFMEA and control plans
- Support and process Non-Conforming Material Reports (NCMRs), CAPAs and Audit Findings
- Weekly reports, updates, administrative task (as needed)
- Conduct testing (as needed)
- Manufacturing and engineering support (as needed)
Minimum Requirements
- Bachelor of Science Degree in Mechanical Engineering, Packaging Science, or similar discipline.
- Minimum of 5 years in medical device or pharmaceutical industry in Manufacturing Engineering, Packaging or Quality Engineering.
- Requires practical knowledge and demonstrated competence within manufacturing engineering, process development, packaging engineering typically obtained through advanced education combined with experience.
- Knowledge and working experience of Lean manufacturing and six sigma practices
- Knowledge and general understanding of ISO 11607 part 2, ASTM and ISTA package test methods is preferred
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