Stryker

Compensation

Full Description

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.