Sr. Software Systems Engineer - Premarket Design Quality
Medtronic
Summary
The Senior Software Systems Engineer on the Neuromodulation and Pelvic Health Premarket Design Quality team will partner 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. This 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.
Job description
Key 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 the development of 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.
Required Qualifications
- Bachelor's degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or a related technical field and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years 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.
Preferred Qualifications
- 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 how quality practices integrate 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.
Requirements
- Bachelor's degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or a related technical field and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years 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.
Benefits
- Health, Dental & Vision Insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life Insurance
- Long-term Disability Leave
- Dependent Daycare Spending Account
- Tuition Assistance
- Incentive Plans
- 401(k) Matching
- Short-term Disability
- Paid Time Off
- Paid Holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
Company overview
Medtronic is a global healthcare technology leader and one of the world's largest medical device companies, founded in 1949 in Minneapolis, Minnesota. The company operates in over 150 countries and employs more than 90,000 people worldwide. Medtronic's mission is to alleviate pain, restore health, and extend life through innovative medical technologies. The company develops and manufactures devices and therapies to treat more than 70 health conditions, including cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With a rich history that began with the invention of the battery-powered pacemaker, Medtronic has grown into a diversified healthcare technology company with four main business units: Minimally Invasive Therapies Group, Diabetes Group, Restorative Therapies Group, and Cardiac and Vascular Group. The company's therapies help approximately 72 million people annually and represent a significant force in advancing medical technology to address some of humanity's most challenging health problems.