Senior Design Quality Engineer (Software/Electrical)

Stryker•Portage, MI

1d•Onsite

About The Position

Stryker is hiring a Senior Design Quality Engineer (Software/Electrical) in Portage, MI to support our Medical Acute Care business. In this role, you will provide quality support for new product development and partner with cross-functional teams, including R&D, Operations, Manufacturing, Suppliers, Testing, Product Security, and Regulatory, throughout the development process. You will support software and electrical design quality activities, risk management, design verification and validation, cybersecurity, process controls, and product design transfer. You may also support post-market quality activities through the change control process and quality improvement projects.

Requirements

Bachelor's degree in Software Engineering, Electrical Engineering, Computer Science Engineering, or a related engineering discipline.
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 (medical device quality management systems) and ISO 14971 (medical device risk management).
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.
Demonstrated 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 closely with R&D to ensure software and electrical product designs meet quality requirements for safety, effectiveness, reliability, manufacturability, cybersecurity, 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 Product Security and R&D to implement cybersecurity best practices and ensure security-related risks and requirements are addressed in the product design.
Participate in design reviews and track how software and electrical design features, specifications, documentation, test methods, and manufacturing processes mitigate risks throughout the development process.
Lead design validation activities, including human factors usability engineering.
Support design verification planning and execution and contribute to the completion of 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 through 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.