Senior Design Quality Engineer; Software/Electrical
Job in
Portage, Kalamazoo County, Michigan, 49002, USA
Listed on 2025-11-21
Listing for:
Stryker Group
Full Time
position Listed on 2025-11-21
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Manufacturing Engineer
Job Description & How to Apply Below
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.
- 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.
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.
- 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.
Position Requirements
10+ Years
work experience
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