- 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
- 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
- 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)
- 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.
- 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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Sr. Manufacturing Engineer - Billerica, United States - Redbock - an NES Fircroft company
Description
Sr. Manufacturing Engineer (Through end of January 2025 // Billerica, MA):
On-site 4-5 days per week (Billerica/Bedford, MA locations)
Join a leading Medical Device company, working within Cardiac Ablation Medical Technology as a Sr. Manufacturing Engineer.
W2 ONLY, unable to sponsor or work C2C**
Top 3 Skills:
Education Required:
Years' Experience Required:
Description:
The Manufacturing Engineer will lead and support various process improvement and remediation activities. Activities to include but not limited to the following:
Minimum Requirements
Preferred Qualifications: