- Act as the liaison between the R&D, Product Management, and Quality as well as component & equipment suppliers and provide "voice of manufacturing" to ensure product/equipment designs incorporate DFM/A principals and/or Lean Six Sigma/DMAIC/DMADV process knowledge.
- Lead the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.
- This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.
- Lead and support Design Transfer to manufacturing activities.
- Minimum B.S. (Mechanical, Electrical, or other related Engineering field equivalent)
- Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment
- Experience working closely with external or third-party suppliers.
- Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments, GR&R) in data analysis for process development and problem-solving.
- Understand equipment concept creation, review approval, build, runoff, FAT, software validation, IQ, OQ, and PQ road map requirements.
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Sr Process Development Engineer
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Whitridge Associates Wayland, United StatesContribute your technical manufacturing, equipment design and project management skills to a dynamic manufacturing engineering team creating precision Coronary catheter devices. The role requires active participation in the NPI and sustaining manufacturing engineering organizatio ...
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Metalor Technologies SA North Attleboro, United StatesMetalor Technologies Americas specializes in providing the highest quality precious metals products and services and continues to adapt and innovate to respond to the ever changing market requirements. Metalor Technologies Americas is a subsidiary of Metalor Technologies, S.A., a ...
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Process Engineer - Wayland, United States - BlackTree Technical Group, Inc.
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Description
Job Description
Job DescriptionThe role requires active participation in the NPI and sustaining manufacturing engineering organization to refine material handling, workstation design, components, assemblies, process documentation, tooling, and test methods to improve efficacy, reliability, manufacturability, and cost for advanced catheter devices.
Key Duties
Required