Senior Design Quality Engineer (Software/Electrical)
About The Position
Stryker is hiring a Senior Design Quality Engineer (Software/Electrical) in Portage, Michigan, to support its Medical Acute Care business. The role provides quality support for new product development and partners with cross-functional teams, including R&D, Operations, Manufacturing, Suppliers, Testing, Product Security, and Regulatory, throughout the development process. The position supports software and electrical design quality activities, risk management, design verification and validation, cybersecurity, process controls, and product design transfer. It may also support post-market quality activities through change control and quality improvement projects.
Requirements
- Bachelor's degree in Software Engineering, Electrical Engineering, Computer Science Engineering, or a related engineering discipline.
- At least 2 years of experience in quality, manufacturing, new product development, software, electrical engineering, or a related engineering field.
Nice To Haves
- Experience within the medical device or manufacturing industry.
- Familiarity with ISO 13485 and ISO 14971.
- Experience supporting software and/or electrical product development, design controls, verification, validation, or cybersecurity activities.
- Experience with data analysis, statistical analysis, sampling plans, statistical process control, or Minitab.
- Applied knowledge of advanced quality tools such as FMEA, Root Cause Analysis, and Mistake Proofing/Poka-Yoke.
- Ability to read and interpret electrical schematics, technical specifications, test requirements, and engineering documentation.
- Six Sigma certification.
- ASQ certification or a master's degree in engineering.
Responsibilities
- Partner with R&D to ensure software and electrical product designs meet quality requirements for safety, effectiveness, reliability, manufacturability, cybersecurity, and usability.
- Support collection of customer and market feedback to inform design requirements and validate designs as they mature through production launch.
- Lead risk management activities for new product development teams, including developing risk management plans and reports, conducting risk reviews, and verifying implementation and effectiveness of design and process risk controls.
- Partner with Product Security and R&D to implement cybersecurity best practices and ensure security-related risks and requirements are addressed in product design.
- Participate in design reviews and track how software and electrical design features, specifications, documentation, test methods, and manufacturing processes mitigate risks throughout development.
- Lead design validation activities, including human factors usability engineering.
- Support design verification planning and execution and contribute to final design verification and validation reports.
- Support product design and quality transfers to internal and/or external manufacturing facilities.
- Analyze and define critical quality attributes for products and processes using risk analysis techniques.
- Partner with Operations and suppliers to implement robust process controls for electrical components, assemblies, software-enabled systems, and manufacturing processes.
- Support PPAP planning by defining and communicating applicable PPAP requirements to component suppliers, and support PPAP approval.
- May support post-market quality activities through change control and quality improvement projects.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
