Mechanical Engineer - Blue Ash, OH - Long Term
  • Blue Ash, Ohio, US
  • +914043515100
418 Days ago
Job Description
  • Own and deliver the development, process characterization and validation of the (electro) mechanical components and assembly process for new product development (NPD) and legacy projects.
  • Create and manage component approval document (e.g. G10002, FAI, PFMEA, Cap Study, Supplier OQ)
  • Manage and review data received from supplier
  • Create and manage test protocols and completion reports (including part logistics, document logistics, managing testing); report findings to cost improvement project team
  • Strong knowledge in cost improvement projects, preferred value engineer certified engineers.
  • Draft and manage design change documents and associated documentation and deliverables
  • Feasibility analysis reports, Tracking/reporting of quote comparisons based on selected suppliers for each SKU, IP assessments, quote package completeness, traceability of data for each SKU in scope and G10002 documentations.
  • Product knowledge and necessary material to transfer knowledge to Supplier
  • Collaborate with the design team to provide DFX (manufacturing and assembly, cost) input and enable translation of product design inputs to product and process outputs.
  • Collaborate with multi-functional partners for supplier selection, project and product risk management and design & process transfer to manufacturing site(s).
  • Own the inputs for manufacturing related activities (prototypes, build, tooling and validation) within the project plan.
  • Transfer knowledge to manufacturing of unit operations enabling transition to daily production.
  • Development and manufacturing experience
  • Experience within medical products/device industry or another highly regulated industry
  • Experience in development of plastics (injection molded), metals and (electro)mechanical components and/or customized semi/automated equipment
Skills & Experience:
  • Minimum 7 plus years of relevant work experience
  • Experience in IQ/OQ/PQ and V&V.
  • Experience with process and measurement/gaging system design along with application of statistical analysis techniques to develop a stable and capable manufacturing process
  • Ability to work in ambiguity, prioritize and lead work, and demonstrate ability to independently judge, define, and manage risk in development of manufacturing solution.
  • Ability to effectively collaborate with multiple internal & external partners
  • NA

Required Skills
  • performance,verification,Installation ,Validation,Mechanical Engineer,Cost improvement,operational

  • 7+ Years of Experience

  • NA

Working Hours / Week
  • 40h