Senior Program Manager - Risk Management

We are seeking a strategic Senior Program Manager in Risk Management to join our Design and Reliability Assurance Engineering team. In this key role, you’ll lead risk management, quality processes, and project assurance across product development and improvement projects to ensure the highest standards of safety, reliability, and compliance.

You’ll drive best practices and support project teams through each phase of development, from concept to commercialization, with a focus on safety and regulatory excellence.

Responsibilities

• Provide leadership, expertise, and guidance on risk management across all project phases, including the development of robust processes, procedures, tools, and technology.
• Lead the implementation of best practices in risk management and usability, continuously improving risk management work products and deliverables to ensure compliance with ISO 14971, IEC 62366, and other applicable standards.
• Actively collaborate with internal and external stakeholders, including design and development partners, on complex projects, ensuring alignment with regulatory and quality requirements.
• Oversee and support New Product Development (NPD), Sustaining Engineering, and Continuous Improvement projects, from initiation through commercialization.
• Lead Design Assurance projects within the CSS Division, including Mergers and Acquisitions (M&A) initiatives, and implement key performance indicators (KPIs) for the risk management process to track effectiveness.
• Guide technical teams in compliance with EU MDR, FDA QSR, ISO 13485, and other industry regulations, ensuring data-driven decisions through statistical sampling and analysis.

Qualifications

• Project Management Skills or a PMP certification would be highly desirable
• Risk Management Expertise: experience in risk management within the medical device or other regulated industries, with subject matter expertise in standards such as ISO 14971 (Risk Management) and IEC 62366 (Usability).
• Problem-Solving Skills: Proficiency in root cause analysis, Design for Six Sigma (DFSS), and DEMAIC methodologies.
• Design Quality Assurance experience in Design Quality Assurance, especially within medical device or pharmaceutical product development.
• Analytical and Statistical Proficiency: Demonstrated ability in statistical sampling and analysis to drive data-driven decision-making.

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

If you are driven by a commitment to quality and eager to be part of a team dedicated to transforming lives, we’d love to hear from you!