Sr. Software Systems Engineer - Premarket Design Quality

Medtronic•Fridley, MN

14d•$120,800 - $181,200

About The Position

The Senior Software Systems Engineer on Medtronic’s Neuromodulation and Pelvic Health Premarket Design Quality team partners with cross-functional development teams to ensure software and system-level design activities are planned, executed, and documented in compliance with applicable quality and regulatory requirements. The role supports new product development by providing quality oversight and technical guidance throughout the design control lifecycle, with a focus on software-intensive medical device systems. The position also contributes to continuous improvement of design quality processes, tools, and templates, and mentors less experienced engineers on design quality practices and compliance requirements.

Requirements

Bachelor’s degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or a related technical field and at least 4 years of relevant experience; or a master’s degree and at least 2 years of relevant experience; or a PhD with 0 years of relevant experience.
Demonstrated experience with design controls, software development lifecycle activities, and verification/validation.
Strong understanding of risk management principles, design failure analysis concepts, and traceability across requirements, design, and testing.
Experience supporting cross-functional product development teams.

Nice To Haves

Strong written and verbal communication skills, with the ability to influence and collaborate effectively.
Ability to manage multiple priorities in a fast-paced environment.
Experience in software engineering, systems engineering, design assurance, reliability, or quality engineering in a regulated industry.
Experience in the medical device industry or another highly regulated environment.
Knowledge of IEC 62304, ISO 14971, ISO 13485, FDA design control expectations, and related standards.
Familiarity with agile development environments and integrating quality practices into iterative development.
Experience with AI used in process development and embedded in products.
Experience with software architecture reviews, cybersecurity considerations, or usability/human factors support.
Advanced degree in engineering or a related discipline.

Responsibilities

Provide design quality support for software and software-enabled medical device development programs from concept through transfer to manufacturing.
Ensure compliance with applicable design control, software lifecycle, and risk management requirements.
Review and contribute to system requirements, software requirements, architecture, and design documentation.
Participate in developing verification and validation strategies for software, system, and integration testing.
Partner with engineering, product development, regulatory, clinical, manufacturing, and quality teams to resolve design quality issues.
Evaluate software development deliverables for completeness, traceability, and regulatory readiness.
Lead software-related risk evaluation and mitigation verification to support risk management activities, including hazard analysis.
Participate in design reviews and provide constructive feedback to improve product quality, safety, and compliance.
Assist in root cause analysis and corrective action activities related to design or software quality issues.
Mentor less experienced engineers on design quality practices, documentation expectations, and compliance requirements.
Contribute to continuous improvement initiatives for design quality processes, tools, and templates.

Benefits

Competitive salary and flexible benefits package.
Short-term incentive through the Medtronic Incentive Plan (MIP).
Health, dental, and vision insurance for eligible regular employees working 20 or more hours per week.
Health Savings Account and Healthcare Flexible Spending Account for eligible regular employees working 20 or more hours per week.
Life insurance and long-term disability leave for eligible regular employees working 20 or more hours per week.
Dependent daycare spending account and tuition assistance/reimbursement for eligible regular employees working 20 or more hours per week.
Simple Steps global well-being program for eligible regular employees working 20 or more hours per week.
Incentive plans for all regular employees.
401(k) plan with employer contribution and match for all regular employees.
Short-term disability, paid time off, and paid holidays for all regular employees.
Employee Stock Purchase Plan for all regular employees.
Employee Assistance Program for all regular employees.
Non-qualified Retirement Plan Supplement, subject to IRS earning minimums.
Capital Accumulation Plan, available to Vice Presidents and above or subject to IRS earning minimums.