Medtronic-posted 4 days ago
Full-time • Mid Level
Onsite • Newton, MA
5,001-10,000 employees

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Join Medtronic as a Software Reliability Engineering Program Manager - Quality Core Team Member and be at the forefront of transforming lives through advanced medical technology! In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to support design, development, and maintenance of software for Affera cardiac electrophysiology systems . By blending technical expertise with a passion for quality, compliance, and improving patient outcomes, you'll have the opportunity to impact global healthcare as the usage of Affera grows rapidly worldwide.

  • Support software quality and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485.
  • Serve as the Quality Core Team Member for Affera software releases .
  • Coordinate quality team members and ensure accountability for completing functional work within program deadlines.
  • Review and approve Design History File and other documentation related to software and security, including plans, change assessments, requirements, design, development, integration, test protocols, test reports, verification, validation, and tooling.
  • Ensure all documentation meets reliability standards and follows QMS processes.
  • Develop and review documentation for traceability, testability, and compliance according to standard operating procedures.
  • Develop expertise in assigned products and projects, including hands-on time in the engineering lab and participation in product training as assigned.
  • Participate in software risk analysis and defect assessments.
  • Influence and analyze software quality metrics for assigned programs, ensuring continuous monitoring and improvement of quality outcomes to achieve required levels of product reliability.
  • Provide software quality support for post-market activities and analysis, including issue assessments, health risk assessments, and CAPAs .
  • Ensure ongoing compliance and reliability of released software products.
  • Recommend design or test methods to achieve appropriate levels of product reliability and security.
  • Propose changes to design or testing as necessary to improve software and/or process reliability .
  • Analyze preliminary plans and develop reliability engineering program strategies to achieve Medtronic, customer, and regulatory reliability objectives for assigned programs.
  • Review and support strategies for product security testing.
  • Obtain and maintain hospital credentialing to attend live EP cases 2–3 times per year to enhance workflow and product knowledge.
  • Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.
  • Bachelor's degree and a minimum of 5 years of relevant experience OR Advanced degree with a minimum of 3 years of relevant experience
  • Minimum of 5 years of experience across any of the following disciplines: software development or testing, quality or reliability engineering, or field/research experience in a cardiac electrophysiology lab.
  • At least 2 years of product development experience within the medical device or another regulated industry.
  • Ability to perform simple coding tasks and effectively read, interpret, and understand existing software code.
  • Excellent written and oral communication skills.
  • Strong knowledge of cybersecurity and the software lifecycle within regulated environments, including design, development, and post-market support.
  • Experience with cardiac and electrophysiology medical specialties.
  • Advanced degree in a relevant field.
  • Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ, or similar).
  • Medtronic offers a competitive Salary and flexible Benefits Package
  • We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
  • Health, Dental and vision insurance
  • Health Savings Account
  • Healthcare Flexible Spending Account
  • Life insurance
  • Long-term disability leave
  • Dependent daycare spending account
  • Tuition assistance/reimbursement
  • Simple Steps (global well-being program)
  • Incentive plans
  • 401(k) plan plus employer contribution and match
  • Short-term disability
  • Paid time off
  • Paid holidays
  • Employee Stock Purchase Plan
  • Employee Assistance Program
  • 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)
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