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The Senior Project Manager – Surgical Tools and Technologies leads complex, cross-functional programs that deliver innovative surgical solutions from concept through commercialization. This role partners closely with R&D, Clinical, Regulatory, Quality, Manufacturing, Supply Chain, and Commercial teams to ensure safe, compliant, and timely delivery of advanced surgical products that improve patient outcomes and surgeon experience.
Job Responsibility:
Lead end-to-end execution of complex surgical device and platform programs across R&D, Clinical, Regulatory, Quality, Manufacturing, and Commercial functions
Define program strategy, scope, milestones, timelines, budgets, and success metrics aligned with business and portfolio objectives
Drive development programs through regulated product lifecycle phases (concept, development, verification & validation, regulatory submission, launch, and post-market support)
Ensure compliance with global regulatory and quality requirements (FDA, ISO 13485, MDR, design controls, risk management)
Manage cross-program dependencies, risks, and trade-offs with a focus on patient safety, clinical effectiveness, and time-to-market
Coordinate manufacturing readiness, supply chain scalability, and design transfer activities
Communicate program status, risks, and decisions to executive leadership and governance forums
Lead change management and decision-making across complex, matrixed organizations
Establish and continuously improve program management processes, tools, and best practices within the Advanced Surgery portfolio
Mentor and coach project and program managers supporting product development
Requirements:
Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related technical field (Master’s degree preferred)
8–12+ years of program or project management experience within medical devices or other regulated product development environments
Proven ability to lead large, complex, cross‑functional, multi‑year development programs
Strong knowledge of medical device development processes, including design controls, risk management, and regulatory/quality requirements
Experience collaborating with Regulatory, Quality, Clinical, Manufacturing, and global launch teams
Systems thinking across hardware, software, and clinical workflows, with experience in electromechanical or surgical/robotic platforms
Expertise in risk, dependency, and change management for complex programs
Strong financial and resource planning capabilities
Data‑driven decision making and clear executive‑level communication and storytelling
Ability to influence and lead without direct authority in matrixed organizations
Nice to have:
Professional certification (PMP, PgMP, SAFe, or equivalent)
What we offer:
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service