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.