Software Reliability Engineering Program Manager (Quality Core Team Member)

Medtronic•Newton, MA

1d•Onsite

About The Position

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.

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

Nice To Haves

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).

Responsibilities

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.

Benefits

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)