Staff Design Quality Engineer (Software/Electrical) Remote

Stryker Corporation; Portage (MI); Sur place; Confidentiel; Plein temps

Résumé du poste

Stryker Corporation in Portage, Michigan is seeking a Staff Design Quality Engineer (Software/Electrical) to ensure product designs meet safety and effectiveness standards. You will partner with R&D, Product Security, and suppliers to drive quality and risk management across the development lifecycle.

The role requires a Bachelor's in Software/Electrical/CS engineering and 4+ years in quality or engineering, with medical device experience preferred.

Qualifications

• Bachelor’s Degree in Software Engineering, Electrical Engineering, or Computer Science Engineering (or other engineering degree with relevant electrical or software experience).
• 4+ years’ experience in quality, manufacturing, new product development, software or engineering.
• Preferred Experience within medical device/manufacturing industry.
• Familiarity with ISO 13485 (medical device standard) and ISO 14971 (risk management standard), IEC-62304 (software development life cycle) Data analysis experience.
• Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
• Demonstrated ability to read and interpret CAD drawings.
• Six Sigma Certification.
• ASQ CSQE certification.

Responsabilités

• Partner with R&D to ensure product designs meet quality requirements for safety and effectiveness.
• Support the collection of market feedback to inform design requirements and validate design with customers as it matures through production launch.
• Work with Product Security and R&D to accomplish product security activities and ensure cybersecurity practices.
• Lead risk management activities for new product development teams with risk plans and reports.
• Partner with Operations and suppliers to ensure robust process controls.
• Participate in design reviews and track design, documentation, and manufacturing process risk mitigation.
• Lead design validation activities including human factors usability engineering.
• Support design and quality transfers to manufacturing facilities.
• Analyze and define critical quality attributes for products and processes via risk analysis.
• Contribute to final design verification and validation reports.
• Support PPAP planning and PPAP submission to suppliers.

Formation

Bachelor’s Degree in Software Engineering, Electrical Engineering, or Computer Science Engineering

Outils

FMEA

GD&T

Root Cause Analysis

Six Sigma

ASQ CSQE

CAD drawings

Minitab

Description du poste

Stryker Corporation in Portage, Michigan is seeking a Staff Design Quality Engineer (Software/Electrical) to ensure product designs meet safety and effectiveness standards. You will partner with R&D, Product Security, and suppliers to drive quality and risk management across the development lifecycle.

The role requires a Bachelor's in Software/Electrical/CS engineering and 4+ years in quality or engineering, with medical device experience preferred.