Principal Manufacturing Engineer

Engineering Recruiting Experts

Principal Manufacturing Engineer

Manufacturing Engineering
  • Location: San Diego, California
  • Type: Direct
  • Job #1864

As a key member of our Device Development team, the Principal Manufacturing Engineer is responsible for strong fundamental project management expertise coupled with comprehensive technical knowledge of combination medical device development, drug filling/capping, transfer to manufacture, and strong device and process Validation and Verification methods.

The successful Principal Manufacturing Engineer has the strong engineering and manufacturing knowledge required to manage multiple combination medical device development projects. This Principal Manufacturing Engineer will have previous direct experience in the complete development life cycle from feasibility through commercialization and a strong character to drive projects to completion while working within a multi-disciplinary team.

REQUIRED EXPERIENCE & SKILLS:
10+ years of experience in as a manufacturing engineer in manufacturing environment
5+ years of experience with with medical devices
5+ years of experience in commercializing devices from V&V phase (verification & validation)
5+ years of project management experience
Experience with medical Device Development Life Cycle and Manufacturing
Experience with statistics, Statistical Process Control & DOE techniques 
BS in Engineering

DESIRED EXPERIENCE & SKILLS:
Experience with medical device and drug device combinations
Experience with with drug fill and finish manufacturing steps
Experience with CMC procedures (chemistry, manufacturing, and controls)
Experience with design controls and FDA QSR 21 CFR Part 820 and ISO 13485
Experience with in HALT/HASS testing and SPC, Lean Methods
Six Sigma or PMP certifications
MS in Engineering

Competitive compensation and relocation is available for this position
**NO SPONSORSHIP IS AVAILABLE FOR THIS POSITION**

Worth Busbee – Senior Technical Recruiter
Email: wbusbee@erestaffing.com
Direct: 1-904-239-4293
Job ID: #1864

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