The Role
As a Senior Design Quality Engineer, you ensure product quality and safety, lead risk management, execute design validation, and collaborate on cybersecurity initiatives in product design.
Summary Generated by Built In
Work Flexibility: Onsite
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.
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.
Top Skills
Biomedical Engineering
Bluetooth
Computer Science Engineering
Electrical Engineering
Fmea
Gd&T
Iso 13485
Iso 14971
Minitab
Software Engineering
Uwb
Wi-Fi
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The Company
What We Do
Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.









