Staff Design Quality Engineer (Mechanical)

What you will do

• Partner closely with R&D to ensure mechanical product designs meet quality requirements for safety, effectiveness, reliability, manufacturability, and usability. Support the collection of customer and market feedback to inform design requirements and validate the design as it matures through production launch.
• Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, and verifying the implementation and effectiveness of design and process risk controls.
• Partner with Operations and suppliers to implement robust process controls for mechanical components, assemblies, and manufacturing processes.
• Participate in design reviews and track how mechanical design features, drawings, specifications, documentation, inspection methods, and manufacturing processes mitigate risks throughout the development process.
• Lead design validation activities, including human factors usability engineering and evaluation of mechanical design performance against user needs and intended use.
• Support product design and quality transfers to internal and/or external manufacturing facilities.
• Analyze and define critical quality attributes for products and processes through risk analysis techniques.
• Contribute to the completion of final design verification and validation reports.
• Support PPAP planning, communicate PPAP requirements to component suppliers, and support PPAP approval.
• What you will need
• Bachelor’s Degree in Mechanical Engineering or related engineering discipline.
• 4+ years’ experience in quality, manufacturing, new product development, or engineering.
• Preferred
• Experience within medical device/manufacturing industry.
• Familiarity with ISO 13485 (medical device standard) and ISO 14971 (risk management standard).
• Data analysis (statistical analysis, sampling plans, statistical process control, Minitab) experience.
• Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, tolerance analysis, Root Cause Analysis, and Mistake Proofing/Poke Yoke. Demonstrated ability to read and interpret CAD models, drawings, specifications, and inspection requirements.
• Six Sigma Certification.
• ASQ CSQE certification.
• United States of America Pay Ranges:
• USN: $89,300 - $148,800 USD Annual
• View the U.S. work location and transparency guide to find the pay range for your location.