Senior Design Quality Engineer (Software/Electrical)

Work Flexibility: Hybrid

Senior Design Quality Engineer (Software/Electrical)

Join one of the world’s leading medical technology companies and help shape the future of healthcare. As a Senior Design Quality Engineer, you will play a critical role in ensuring our innovative products meet the highest standards of safety and effectiveness—ultimately improving patient outcomes worldwide.

Work Flexibility: 

Hybrid: Candidates must reside within a commutable distance to Portage, MI and be able to work onsite several times per week.

What you will do:

• Ensure product designs meet quality, safety, and effectiveness requirements by partnering with R&D and cross-functional teams.
• Lead risk management activities for new product development, including creating plans, conducting reviews, and verifying risk controls.
• Execute design validation activities, including human factors engineering and usability testing.
• Collaborate with Product Security and R&D teams to implement cybersecurity best practices in product design.
• Participate in design reviews and track risk mitigation throughout development and manufacturing processes.
• Support product design transfers to internal and external manufacturing facilities.
• Analyze and define critical quality attributes for products and processes using risk analysis techniques.
• Partner with suppliers and manufacturing to implement robust process controls and quality improvements.

What you will need:

Required Qualifications:

• Bachelor’s degree in Software Engineering, Electrical Engineering, Computer Science Engineering, Biomedical Engineering, or related field with relevant experience.
• 2+ years of experience in quality, manufacturing, new product development, software, or engineering.

Preferred Qualifications:

• Experience in the medical device or manufacturing industry.
• Familiarity with ISO 13485 and ISO 14971 standards.
• Knowledge of statistical analysis tools (e.g., Minitab) and advanced quality tools (FMEA, GD&T, Root Cause Analysis).
• Experience with Software Development and Connectivity technology such as Wi-Fi, Bluetooth, UWB (ultra wide band)
• Ability to read and interpret CAD drawings.
• Six Sigma certification.

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.