our client in northridge, ca is looking for a mechanical engineer. If interested, please apply to this ad or send your resume and contact details with the job # and job title in the subject line to email@example.com ROLE DETAILS: |
- Define, validate and document inspection methods and acceptance criteria for components and subassemblies.
- Perform and / or Guide the planning and execution of gage R&R studies, document results in engineering reports.
- Review Diabetes design specifications (drawings and specifications) for accuracy and adequacy and provide timely feedback to the authors and quality assurance functions.
- Plan and Execute activities to facilitate the verification and validation of components and sub-assemblies produced by suppliers for Diabetes devices.
- Participate in risk management and design review activities as needed.
- Author quality plans and reports as instructed by management.
- Guide and support supplier’s verification and validation activities.
- Drive and facilitate supplier corrective action and process improvement.
- Review design inputs (specifications) and design outputs (reports, drawings, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer.
- Review & approve product verification and validation plans and reports.
- Participate in Change Control Board (CCB) to review and approve engineering change requests.
- Participate in Material Review Board (MRB) to review & disposition nonconformities and to coordinate & supplier corrective actions.
- Perform other duties as assigned.
• Bachelor of Science Degree or Associate Engineering degree.
• Minimum 3 years work experience.
• Working knowledge of inspection tools and methods – “smartscope”, CMM, measurement fixtures (design and validation), gauges.
• Working knowledge of industrial statistics – sampling plans, process capability, SPC, DOE.
• Excellent knowledge of drafting practices, GD&T.
• Working Knowledge of injection molded plastic components quality control and measurement.
• Experience working with remote suppliers and facilities, both domestic and international.
• Working knowledge of problem solving and statistical methods as applied to process and product quality.
• Familiar with process validation (IQ / OQ / PQ)
• Self-Starter and accountable, with sharp focus on quality and customer experience. DESIRED QUALIFICATIONS:
• Knowledge of injection molded plastic components quality control and measurement.
• Familiar with ISO quality system (ISO13485), USFDA Quality System Regulation, and relevant international standards
• Certified Lean or Six Sigma Black Belt.
• Project Management experience.
• Familiar with in pFMEA, dFMEA, risk analysis and management.
• Familiar with Gears design and metrology – plastics and metals
• Familiar with SPICE / SPACE program
• Working knowledge of metrology data acquisition.
• ASQ certification in Quality or Reliability
• An ability to interact with senior external personnel on significant technical matters often requiring coordination between organizations.
Creative Solutions Services, LLC - 10 months ago