Post-Market Software Reliability Engineering...

In this exciting role as a Post-market Software Reliability Engineering Manager, you will have responsibility for leading the organization's post-market quality processes to ensure product safety, regulatory compliance, and customer satisfaction. This role oversees post-market surveillance, field action/recall support, and quality system effectiveness while driving continuous improvement across global operations. The position partners closely with internal business partners (Platform teams), Regulatory Affairs, R&D, Manufacturing, Clinical, and Commercial organizations to identify and mitigate product quality risks throughout the product lifecycle.

This position provides software reliability engineering leadership for R&D. The candidate will be a key leader and player in cross-functional teams and serve as a focal point and technical representative for reliability, safety, and quality functions.

As part of R&D project teams, the Post-market Software Reliability Engineering Manager will lead a team of post-market software reliability engineers. This team will work with multidisciplinary teams and provide leadership for Design for Reliability (DfR), guidance on technical quality issues, engagement in design and risk reviews, and contribute to development activities., The Functional Manager is accountable for day-to-day software quality management quarterly objectives and overall engagement of the organization. This includes responsibility for building and maintaining a team that consistently delivers embedded software functional excellence. The Functional Manager is ultimately accountable for their team's performance and execution. In general, the following responsibilities apply for the Post-Market Software Reliability Engineering Manager role. This includes, but is not limited to the following:

Post-Market Quality Leadership

• Lead post-market quality strategy and execution across the Patient Care Systems product portfolio.

• Establish and lead execution for operational objectives OKRs, KPIs, and quality metrics.

• Provide leadership and oversight for product complaint and trend analysis.

• Partner with pre-market quality leadership/team to deliver continuous improvement initiatives to enhance product quality and customer experience.

Complaint Investigations

• Oversee root cause investigations and corrective actions.

• Review complaint trends and escalate emerging risks appropriately.

• Ensure compliance with global quality standards and plans.

• Provide guidance on responding to additional questions from regulatory agencies for complaint reports.

Post-Market Surveillance

• Manage post-market surveillance programs, including trend analysis and risk monitoring.

• Oversee preparation and review of surveillance reports, performance metrics, and health risk assessments.

• Monitor product performance in the field and identify opportunities for risk reduction.

Leadership Focus

• Lead team in communicating product issues and determining potential next steps.

• Work with internal teams to ensure field actions or other field communications are executed per plan.

• Chair or participate in product quality reviews, CAPA boards, decision-making committees.

• Maintain compliance with global post-market regulatory requirements.

Quality System Management

• Ensure compliance with Quality Management System (QMS) requirements.

• Support internal audits, external audits, inspections, and regulatory assessments.

• Drive CAPA effectiveness and process harmonization efforts.

• Implement policies, procedures, and quality standards.

• Bachelor's degree in science, technology, engineering, or math and minimum of 7 years of technical work experience OR advanced degree in science, technology, engineering, or math, with 5 years of technical experience and 5 years of demonstrated managerial experience

Nice to Have

• Certified Reliability Engineer (CRE), Certified Software Quality Engineers (CSQE) or equivalent certification

• Ability to communicate complex technical investigations to high-level leadership, customers, etc

• Experience in software fault tolerant design, fault prevention techniques, design for testability methods, software FMEA and FTA

• Experience with Software Reliability Engineering models including reliability growth models

• Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications and cloud-based services

• Experience with automated and/or manual software tests and DevOps processes

• Experience with Agile or behavior-based development

• Experience in medical devices or other regulated industry

• Experience working with IEC 62304, ISO 13485, and ISO 14971 standards

• Knowledge of Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), Design for Reliability and Manufacturability (DRM), or other robust design practices

• Proficient in spreadsheets and project management tools

• Demonstrated success in project management, with exceptional influence management skills

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.

Salary ranges for U.S (excl. PR) locations (USD):$150,400.00 - $225,600.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact., The Cardiac and Vascular Group brings all our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions. This position is in Mounds View, MN. within the Cardiac Rhythm Management (CRM) unit. 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 are working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects. We believe that when people from different cultures, genders, and points of view come together, innovation is the result -and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive., About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future., If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. 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. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will… + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.