Software Reliability Engineering Program Manager
23 hours ago
We anticipate the application window for this opening will close on - 3 Nov 2025 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 LifeAt 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.Primary ResponsibilitiesSupport 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.Travel Requirement:
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