Manufacturing Engineer Manager

(none selected) | Direct Hire

Post Date: 05/26/2017 Job ID: (JOS000006499) Industry: Software/Hardware

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.

Requirements:
- 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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