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 talent 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 included, respected, empowered and recognised.

##What You Can Expect

As a Mechanical Engineering Manager, you will serve as a technical leader responsible for driving innovation, ensuring product quality, and guiding cross-functional teams through the design, development, verification, and commercialization of medical devices. You will provide deep technical expertise, mentor engineers, and help define the technical strategy that supports our mission to improve patient outcomes and advance healthcare technology.

##How You'll Create Impact

• Mechanical subject matter expert (SME) for all OrthoGrid technologies and product lines;
  o Lead mechanical subsystem strategy long-term hardware roadmap for OrthoGrid products.
• Lead complex design and development activities, from concept through design transfer and manufacturing and mechanical design robustness across NPI and sustaining activities;
• Develop and maintain design control documentation (e.g., design inputs, risk analysis, verification/validation protocols):
  o Support system-level verification, validation, and investigations.
• Generate and evaluate innovative solutions to complex engineering challenges;
• Support feasibility studies, prototyping, and design optimization;
• Partner with Quality, Regulatory, and Clinical teams to ensure design compliance with FDA, ISO 13485, and other global regulatory standards and with suppliers and manufacturing partners to ensure design-for manufacturability and scalability;
• Provide cross-functional leadership during system integration, technical guidance and mentorship to junior engineers and project teams;
• Own technical reviews and lead in design and risk assessments;
• Ensure adherence to design control, risk management, and change control procedures per ISO 14971 and 21 CFR Part 820:
  o Define and maintain mechanical architecture, design standards and documentation, and engineering best practices.
• Support 510(k) submission activities.

##What Makes You Stand Out

• Knowledge of biocompatibility, sterilization, and validation processes;
• Familiarity with Agile development and systems engineering practices;
• Demonstrated leadership and mentoring experience;
• Strong problem-solving and analytical thinking;
• Excellent communication and collaboration skills;
• Ability to operate effectively in a fast-paced, cross-functional environment;
• Commitment to patient safety, product quality, and regulatory compliance;
• Strategic and systems-level thinking.

##Your Background

• Master’s or PhD in Engineering or related field;
• Experience with Class I or Class II;
• Proven track record of leading technical projects through full product lifecycle;
• Strong understanding of design controls, risk management, and regulatory compliance; (FDA, ISO 13485, ISO 14971);
• Proficiency with CAD, FEA, or equivalent engineering design and analysis tools.

##Who We Are

At Orthogrid Systems, we develop advanced software applications that assist surgeons during intraoperative procedures using fluoroscopic imaging systems. We are seeking a Senior Software Engineer who will make a significant and tangible contribution to the design, development, and deployment of mission-critical medical software.

More information on our website: OrthoGrid | Zimmer Biomet

EOE/M/F/Vet/Disability