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Sr. Manufacturing Engineer

4 months ago

Billerica, United States Redbock - an NES Fircroft company Full time

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:

  1. Evaluate, develop, validate and implement manufacturing processes and process improvements for Medical devices or regulated industries
  2. Problem solving, root cause investigation, experience with CAPA
  3. 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

Description:

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.
  • Knowledge and working experience of Lean manufacturing and Six Sigma practices

Preferred Qualifications:

  • Knowledge and general understanding of ISO 11607 part 2, ASTM and ISTA package test methods is preferred