Senior Design Quality Engineer (Software/Electrical)

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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.