Product and Systems Engineering Director

Overview

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.

This is an on-site position.

What You Can Expect

Owns the end-to-end coordination of system design, clinical workflow, and cross-functional execution for an orthopaedic surgical robotics platform focused on orthopaedic joint reconstruction. Ensures the robotic system(s) functions as a single, safe, validated, and commercially viable platform in the operating room and across the full product lifecycle.

Serves as the primary integrator between Engineering, Product, Clinical Affairs, Regulatory, Quality, Manufacturing, and Commercial teams, translating surgeon, user, and patient needs into robust, traceable system requirements and successful global deployment.

Monogram's surgeon-guided semi- and fully autonomous robotic technologies are expected to add new and differentiated capabilities to Zimmer Biomet's already broad suite of customer-centric technology solutions. By joining this team you will be taking part in cutting edge technology used to improve patient outcomes and relieve pain for patients across the globe. Excited to join us? Submit your application now.

How You'll Create Impact

• Lead the team responsible for system-level risk management, hazard analysis, and FMEA, ensuring alignment with FDA, EU MDR, ISO 14971, ISO 13485, IEC 60601, and IEC 62304 requirements
• Own end-to-end requirements management, including user needs, system and software requirements, traceability, and change control across the product lifecycle
• Oversee clinical protocol drafting and execution in partnership with Clinical Affairs, ensuring regulatory and design control alignment and ensure verification and validation strategies meet regulatory, clinical, and engineering expectations
• Own system-level alignment across hardware, software, instruments, imaging, and clinical workflow, ensuring the platform functions as a unified robotic system in the operating room
• Partner closely with the Director of Software to ensure system requirements, risk management, and clinical workflows are translated into actionable software requirements
• Drive coordination between UX, visual design, software implementation to ensure clinical usability, safety, regulatory compliance; own final system-level trade-off decisions across safety, performance, timeline, and regulatory risk in alignment with Engineering VP
• Translate clinical and product strategy, surgeon input, and field feedback into clear, actionable system and software requirements for Engineering
• Partner with PM to define & maintain the product roadmap, support clinical readiness, site onboarding, surgeon training strategies for global deployment; partner with Commercial and Marketing to ensure clinical, regulatory, system readiness for surgeon adoption
• Partner with Clinical Affairs and Outcomes to define, support, and execute clinical trials, outcomes studies, clinical trial protocols, ensuring alignment with regulatory, product, system validation objectives. Serve as technical & clinical SME
• Lead and manage the Strategic Program Manager role, ensuring strong cross-functional execution, operational rigor in support of product delivery & business objectives. PM oversee coordination across Sales & Marketing, MedEd, QARA, R&D, Procurement, Operations, SC
• PM will ensure integrated planning, timelines, milestone tracking, and dependency management across product and business initiatives, serve as an executive escalation point for cross-functional risks, resource conflicts, and stalled or at-risk programs
• PM will establish and maintain program governance, status reporting, leadership communication cadence, identify breakdowns in communication, ownership, or handoffs and implement practical process improvements and build and maintain clear escalation paths
• Lead and develop multi-disciplinary teams across Systems Engineering, Product Support, Software Systems, and Clinical Program Management, including teams of ten or more contributors
• Drive governance, metrics, operational rigor across development, clinical, and regulatory workflows and proactively identify & mitigate technical, clinical, regulatory, deployment risks. Align Manufacturing, Service, and Field teams to ensure scalable deployment

What Makes You Stand Out

• Deep understanding of TKA clinical workflow and surgeon needs
• Systems-level thinking across robotics, software, hardware, and disposables
• Strong command of software lifecycle, edge case analysis, and usability engineering in regulated environments
• Strategic product leadership for capital equipment portfolios
• Executive communication and cross-functional influence
• Risk-based decision-making in clinical and regulatory contexts
• Team development and performance leadership
• Direct experience with robotic-assisted Total Knee Arthroplasty, navigation systems, or smart orthopaedic instrumentation
• Established relationships with orthopaedic surgeons and clinical KOLs
• Experience leading global regulatory submissions and post-market clinical evidence generation

Your Background

• Minimum Requirements: Bachelor's Degree and 8 years of relevant experience, or Associate's Degree and 10 years of relevant experience, or High School Diploma or Equivalent and 12 years of relevant experience
• Preferred Qualifications:
  • Bachelor’s degree in Engineering, Biomedical Engineering, or related technical field, with a Master’s degree or PhD strongly preferred
  • Twenty or more years of experience in medical devices, surgical robotics, or complex regulated systems development with strong preference for orthopaedic medicine
  • Proven technical leadership across systems engineering, software development, and clinical and regulatory execution
  • Demonstrated people management experience, including leading and developing teams of ten or more direct and or matrixed reports
  • Strong working knowledge of FDA, EU MDR, ISO 13485, ISO 14971, IEC 60601, and IEC 62304, and medical robotics regulatory pathways
  • Track record of delivering capital equipment or robotic platforms from development through clinical validation and commercialization

Travel Expectations

• Up to 20% with a valid passport

EOE

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