Sr. Software Systems Engineer - Premarket Design Quality

Fridley, Minnesota, United States of America · full time · Senior

$120,800 – $181,200

Listed on Medtronic’s own careers site. You apply with them directly — we never stand between you and the employer.

What this role is

This role supports the development of software-intensive medical devices at Medtronic by providing quality oversight, design controls expertise, and regulatory guidance throughout the product lifecycle. It suits engineers with systems and software development experience who want to combine technical depth with quality and compliance responsibilities in a regulated healthcare environment.

Our summary, not Medtronic’s wording. The full posting is on their site.

Skills this role names

What they ask for

Required

Bachelor's degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or related field with 4+ years relevant experience (or Master's with 2+ years, or PhD)
Design controls experience
Software development lifecycle activities and verification/validation experience
Risk management principles and design failure analysis knowledge
Requirements traceability across design and testing
Cross-functional product development team support

Nice to have

Strong written and verbal communication and collaboration skills
Ability to manage multiple priorities
Software engineering, systems engineering, design assurance, or quality engineering experience in regulated industry
Medical device or highly regulated environment experience
Knowledge of IEC 62304, ISO 14971, ISO 13485, and FDA design control expectations
Familiarity with agile development and quality practice integration
AI experience in process development and embedded products
Software architecture reviews, cybersecurity, or usability/human factors support experience
Advanced engineering degree