Program Manager for Remote Patient Monitoring responsible for operational, financial, and clinical oversight at Essen Health Care. Leading a team to improve patient outcomes and efficiency.
About the role
- Senior Program Manager at Medtronic leading post-market surveillance strategies and ensuring patient safety compliance. Collaborating cross-functionally to drive innovation and regulatory excellence.
Responsibilities
- 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.
- 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.
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.
- Bachelor’s degree in Engineering, Life Sciences, or related STEM field (Nice to Have)
- Advanced degree preferred (e.g., MS, or PhD) in STEM fields (Nice to Have)
- Proven track record of establishing and improving PMS processes and systems with a focus on patient safety.
- 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.
- 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 (Nice to Have)
- Manufacturing Experience (Nice to Have)
- Green Belt (Nice to Have)
- Six Sigma/DRM Training/Certification (Nice to Have)
- Demonstrated working knowledge of process validation, statistical methods, risk management
Benefits
- 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)
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Program Manager, Marketing at Baseten overseeing operational execution of marketing initiatives. Driving campaign execution and cross - functional alignment in a rapidly growing AI company.
Program Manager III at CrowdStrike overseeing large - scale infrastructure initiatives in cybersecurity. Collaborating with engineering teams to ensure timely execution and communication across global teams.
Program Manager driving geographic expansion strategies within MedTech surgery. Leading project execution while maintaining collaboration across diverse teams and stakeholders.
Program Manager driving healthcare technology innovations as a core member of the systems PMO team. Focused on design, usability, and safety validation of robotic systems with team collaboration and Agile methodology.
Senior Program Manager for DLA spares portfolio at Boeing ensuring USAF platform readiness. Leading execution of transactional spares and Performance - Based Logistics programs.
Solutions Programme Manager responsible for managing GIS tooling solutions and driving customer outcomes at Computacenter. Collaborating with stakeholders and supporting pre - sales engagements in a hybrid environment.
Principal Program Manager overseeing strategic delivery and project implementation at PointClickCare, a health tech leader. Responsible for managing client relationships and project alignment with transformation objectives.
Clinical Program Director overseeing treatment of clients in AMFM Healthcare’s programs. Leading therapeutic programming and clinical supervision while ensuring compliance with regulations and best practices.
Mobile WorkSource Services Analyst providing workforce services directly to underserved communities in Oregon. Driving a Mobile Job Center and offering high - quality employment services and outreach initiatives.