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SCstryker.com logo

stryker.com

Michigan

Senior Design Quality Engineer (Software/Electrical).

ON-SITESENIOR LEVELQA$77.7K–129.5K/YR
Work Flexibility: Onsite 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. What you will do 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. What you will need 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. Preferred Qualifications 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. United States of America Pay Ranges: USN: $77,700 - $129,500 USD Annual View the U.S. work location and transparency guide to find the pay range for your location. Travel Percentage: 10% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.
Pay
$77.7k–129.5k/yr
Where
Michigan · Portage 3800 East Centre Ave · United States of America
Work
On-site
Type
Not stated
Posted
23 Oct, 2026
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