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Senior/Lead Manufacturing Engineer
A start up company south of Boston is looking for a Lead Manufacturing Engineer
A chance to be part of a growing company, build out a team/processes.
About Our Client
Start up Medical Device Company with a unique technology; expanding their manufacturing team in Boston
Reporting to the VP of Operations, the Lead Manufacturing Engineer will support new product introduction efforts with these innovative medical device products.
Responsibilities of the Lead Manufacturing Engineer include:
- Acting as a team leader working with R&D, Quality and Manufacturing, the Lead Manufacturing Engineer will work with scale up production of processes and plastics and electro-mechanical equipment on the manufacturing floor
- Manage Manufacturing Process from outside by participating in CAPA, MRB, ECO and all design reviews for all new and existing products.
- Identify and execute process validations including generation of plans, protocols and reports.
- Work with the Materials Manager and Planner to ensure top level planning is in place and correct for quarterly manufacturing goals.
- Support global new product introduction, production floor support in a clean room and production transfer efforts
- Documentation and write protocols of IQ, OQ and PQ activities
- Working with scale-up production and equipment within a high volume, sterile clean room environment.
- Manufacturing Processes for Lean Manufacturing (5S)
The Successful Applicant
The Lead Manufacturing Engineer should have the following:
- Bachelors in Mechanical, Electro-Mechanical or Manufacturing Engineering required
- 7-12 years of experience
- Strong background with sustaining engineering and DFM
- Electro-Mechanical product experience is preferred
- Life Sciences industry experience preferred - Medical Device, Biotech - within an FDA regulated, cGMP environment
- Strong documentation experience highly desired
- Six Sigma Black Belt a strong plus
- IQ, OQ, PQ and DOEs experience
- Knowledge of ISO 13485 and QSR/cGMP requirements preferred
- Excellent communication skills and ability to work independently with strong leadership skills
- Proven ability to multi-task and adapt quickly to an ever-changing fast-paced environment
What's on Offer
- Competitive base salary
- Exciting opportunity to join a growing team
- Thrive in a start-up environment
- Fast track to management