Senior Director, Program Management
$169,580–$233,178 year
On-siteChicago, Illinois, United States
Job Summary
Lead large, complex Systems and Informatics product development programs from initiation through commercialization and lifecycle management within a global, regulated medical device environment. Drive cross-functional alignment across R&D, Marketing, Quality, Regulatory Affairs, Manufacturing, Supply Chain, Service, and Operations to achieve strategic business objectives. Provide strategic program leadership by balancing scope, schedule, quality, technical risk, cost, and business priorities while managing substantial program budgets and global teams. Lead executive program governance by communicating program health, milestones, risks, and mitigation plans to Integrated Business Planning teams and senior leadership. Ensure successful completion of all Product Delivery Excellence phase gate requirements and proactively manage technical, regulatory, operational, and business risks throughout the product lifecycle.
Required Qualifications
- Extensive experience leading complex, integrated medical device product development programs involving hardware, software, automation, systems integration, and laboratory diagnostic solutions within a regulated environment
- Demonstrated success leading multidisciplinary R&D teams through all phases of product development, verification, validation, regulatory approval, commercialization, and sustaining engineering
- Proven ability to align program execution with business strategy while maintaining a strong product value proposition
- Experience leading global cross-functional teams across R&D, Marketing, Quality, Regulatory Affairs, Manufacturing, Supply Chain, Service, and Operations
- Strong knowledge of medical device product development processes, Design Controls, risk management, and FDA and international regulatory requirements
- Demonstrated ability to proactively identify program constraints, evaluate technical and business trade-offs, and drive timely executive decisions
- Excellent leadership, communication, negotiation, and influencing skills with the ability to build alignment across diverse global organizations
- Experience managing third-party development partners, strategic suppliers, and OEM relationships
- Bachelor's degree in engineering, Mechanical Engineering, Electrical Engineering, Chemical Engineering, Life Sciences, Systems Engineering, or a related technical discipline
- 10+ years of progressively responsible leadership experience managing complex medical device or laboratory diagnostics product development programs
- 5+ years of experience within a regulated medical device, laboratory diagnostics, biotechnology, or life sciences organization
- Project Management Professional (PMP) certification or equivalent program management certification
- Must be able to work with controlled technology in accordance with US export control law
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