Lead Systems Engineer

Responsibilities may include the following and other duties may be assigned

• Conduct gap assessments of product development processes and documentation against applicable medical device standards and regulations.
• Evaluate compliance with:
  • ISO 13485 (Quality Management Systems)
  • ISO 14971 (Risk Management)
  • IEC 62304 (Software Lifecycle)
  • FDA 21 CFR Part 820 (Quality System Regulation)
  • EU MDR (Medical Device Regulation), if applicable
  • IEC 60601(Basic safety and essential performance of medical electrical equipment)
• Review risk management files, design history files (DHF), software documentation, and quality processes.
• Identify non-conformities, process weaknesses, and areas requiring remediation.
• Collaborate with R&D, Quality, Regulatory, and Engineering teams to develop and implement corrective and preventive actions (CAPAs).
• Prepare clear reports and presentations to communicate findings and recommendations to leadership.
• Support internal and external audits, inspection readiness, and regulatory submissions.
• Stay informed of evolving regulatory requirements and assist in updating internal procedures and documentation accordingly.
• Collaborate and maintain excellent working relationships with team members and stakeholders.
• Follow Medtronic ENT product development standards and practices.
• All activities must be performed in compliance with the Quality System.
• Performs duties in compliance with environmental, health and safety related site rules, policies, and governmental regulations.
• All other duties as assigned.
• Travel requirement: 10-20%

Required Knowledge and Experience

• Bachelor s degree in Biomedical Engineering, Systems Engineering, Electrical or Electronics Engineering or related discipline
• 12+ years of experience with a Bachelor s degree
• 10+ years of experience with a Master s degree or higher
• 3+ years of experience in medical device industry with focus on product life cycle knowledge and systems documentation.
• Hands-on experience performing gap assessments or audits against international standards (ISO 13485, ISO 14971, etc. ).
• Strong understanding of medical device development lifecycle and associated documentation.
• Experience with risk management, design controls, and QMS processes.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and in cross-functional teams.
• Self-motivated with strong problem-solving skills and the ability to work independently.

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain, restore health, and extend life unites a global team of 95, 000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here