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Senior Program Manager, Post-Market Surveillance

Senior Program Manager, Post-Market Surveillance

Medtronic PlcBoston, MA, US
4 days ago
Job type
  • Full-time
Job description

Senior Program Manager, Post-Market Surveillance (PMS)

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.

Medtronic is seeking a highly skilled and innovative Senior Program Manager, Post-Market Surveillance (PMS) to join our PMS Center of Expertise. The successful candidate will play a critical role in driving excellence in PMS strategies and practices, ensuring effective PMS processes dedicated to patient safety and global regulatory compliance, and establishing Medtronic as a leader in state-of-the-art post-market surveillance.

With a "Put Patients First" mindset, this position demands an action-oriented, strategic thinker who is also grounded in practical, collaborative approaches to delivering impactful results. Reporting to the leader of Risk Management and PMS Centers of Expertise, the PMS Expert will lead initiatives to improve the PMS processes, patient safety, and organizational success while fostering effective cross-functional partnerships.

This is an on-site position that requires candidates to work in the Mounds View, MN, Lafayette, CO, Boston, MA, Memphis, TN, or Santa Rosa, CA office 4-days per week minimum.

Responsibilities may include the following and other duties may be assigned :

  • Assess the current Post-Market Surveillance (PMS) processes and develop proactive, safety / compliance driven strategies.
  • Monitor and analyze post-market surveillance data, metrics and KPIs (e.g., complaints, adverse events, external signals) to identify risks, trends, and opportunities for process and product improvement.
  • Advise Operating Units and enterprise functions regarding post-market surveillance processes and activities in collaboration with Quality, Regulatory Affairs and Medical Safety teams.
  • Support internal and external audits related to PMS activities, serving as the subject matter expert (SME) and ensuring alignment with global regulatory standards.
  • Identify opportunities to improve seamless integration of PMS with risk management frameworks, including methodologies to ensure the life-cycle processes, activities and documentation alignment and integration.
  • Collaborate with Risk Management Center of Expertise (COE) experts and cross-functional teams to proactively assess and mitigate risks associated with Medtronic products, ensuring patient-centric decision-making.
  • Drive initiatives to position Medtronic as a best-in-class organization in PMS by identifying and implementing innovative tools, technologies (e.g., Digital, AI / ML), and methodologies.
  • Proactively address gaps in systems and processes, ensuring alignment with evolving regulatory expectations and industry standards.
  • Establish and optimize meaningful KPIs to measure PMS effectiveness, performance and efficiency, ensuring actionable insights and continuous improvement.
  • Maintain and continuously improve quality system procedures related to PMS to meet evolving regulatory requirements and industry best practices.
  • Foster strong partnerships across internal teams, including OU teams, Quality, Regulatory, R&D, and Medical Safety, to ensure productive collaboration and alignment on PMS activities.
  • Provide strategic guidance and leadership to support PMS-related initiatives across multiple business units, driving safety and compliance-oriented solutions.
  • Represent the PMS COE in cross-functional and executive meetings, ensuring alignment with organizational goals and regulatory priorities.
  • Promote a culture of collaboration, accountability, and excellence.

Must Have : Minimum Requirements

  • Bachelor's degree required
  • Minimum 7 years of experience in post-market surveillance, risk management, CAPA, FCA (recalls), and complaints handling within the medical device industry or other regulated health care industries.
  • OR advanced degree with a minimum of 5 years of experience in post-market surveillance, risk management, CAPA, FCA (recalls), and complaints handling within the medical device industry or other regulated health care industries.
  • Nice to Have :

  • Bachelor's degree in Engineering, Life Sciences, or related STEM field.
  • Advanced degree preferred (e.g., MS, or PhD) in STEM fields.
  • Proven track record of establishing and improving PMS processes and systems with a focus on patient safety.
  • Experience working across multiple business units and geographies.
  • Strong understanding of EU MDR, FDA, and other global regulatory requirements.
  • Strong working knowledge of global regulations (e.g., FDA's 21 CFR 820, EU MDR and other global regulations) and international standards (e.g., ISO 13485 and ISO 14971).
  • Exceptional leadership, communication, analytical, influencing and interpersonal skills.
  • Strategic thinker with the ability to balance visionary goals with realistic, practical execution.
  • Action-driven and focused on delivering measurable results.
  • Adept at building cross-functional partnerships and influencing stakeholders effectively.
  • Experience leading complex projects / programs.
  • Experience with SPC, CAPA, NCMR, PDP processes.
  • Effective planning and organization skills including the proven ability to work against multiple objectives simultaneously.
  • Ability to establish and maintain a trusted role with the various stakeholders in coordinating multiple functions across the organization.
  • PMP Certification.
  • Manufacturing Experience.
  • Green Belt Six Sigma / DRM Training / Certification.
  • Demonstrated working knowledge of process validation, statistical methods, risk management.
  • Physical Job Requirements

    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    For Office Roles : While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

    Benefits & Compensation

    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) : $168,800.00 - $253,200.00 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

    About Medtronic

    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

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