Manufacturing Engineering Manager

(none selected) | Direct Hire

Post Date: 06/06/2017 Job ID: JOS000006499 Industry: Software/Hardware

Summary: In this key position, you will have total management responsibility for developing and executing an assembly process implementation plan. You will serve as a liaison between research and development and manufacturing sites to implement cost effective, scalable manufacturing solutions that fulfill company objectives and Class III PMA Medical Device requirements.

Essential Job Functions, may include but are not limited to:
- Project Lead / primary interface with selected contract manufacturers managing design transfer, process qualification and production; providing technical, tactical and strategic support as needed.
- Develop, document and implement assembly processes that are compliant to FDA 21 CFR regulations and achieve COGS / capacity objectives.
- Support the selection and qualification of approved supplier’s / contract manufacturers.
- Evaluate and qualify all components and assembly processes; partnering with quality control, operations and R&D to ensure compliance to specifications.
- Develop, implement and execute process validation protocols and reports, including assembly tooling qualification.
- Support materials management by optimizing procurement and distribution of components, assemblies and finished goods.
- Support quality and engineering in technical troubleshooting, driving problem resolution.
- Serve as the manufacturing representative within NCMR material review board.
- Responsible for managing contracted or FTE direct reports.
- Provide regular status and performance updates to management.

- Minimum 10 years of mechanical assembly experience with a progressive increase in responsibilities.
- BS in Mechanical Engineering, Industrial Engineering or Manufacturing Engineering, or equivalent. (Masters Preferred)
- Minimum of 3 years of experience within the medical device industry serving Class II or Class III medical device product. Strong preference provided to PMA medical device experience.
- Must have a core understanding of COGS contributing factors and demonstrated ability in achieving 80%+ cost reduction targets through the application of Lean Flow and DFM principles.
- Expert in process validation and risk management including Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), PFMEA and software validation.
- Must have experience managing OUS contract manufacturers (Asia or Mexico preferred).
- Experience utilizing 6 sigma and 5S process practices.
- Experienced in statistics based performance analysis, including sample size definition, CPK / PPK calculations, Pareto analysis and calculation of other Key Performance Indicators.
- Strong mechanical aptitude; working knowledge of component and assembly production processes.

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