Senior Product Development Engineer (PDE) - Augmented Reality and Robotics

• We are seeking an experienced a Product Development Engineer to provide technical leadership for the development and delivery of innovative orthopedic technologies. This role directs technical execution across electrical, mechanical, software, materials, biomedical, and systems engineering disciplines to translate clinical and product needs into safe, effective, and commercially viable medical devices.
• The PDE will provide system-level technical direction from concept through commercialization, with primary areas of concentration in augmented reality orthopedic navigation and/or integration of orthopedic navigation with robotic systems for knee and shoulder applications. The role requires a hands-on technical leader capable of defining system architecture, driving complex multidisciplinary integration, resolving technical challenges, and guiding engineering teams toward successful product development.

• Serve as a technical lead with primary areas of concentration to include augmented reality orthopedic navigation and/or navigation technologies applied to robotic systems for knee and shoulder applications.
• Be able to provide product development guidance for navigation and robotic technologies to support safe and effective robotic-assisted orthopedic procedures, including system architecture, interfaces, coordinate systems, tracking, instrumentation, workflow, control functions, and overall system performance analysis.
• Lead technical development activities that translate clinical needs and technology concepts into complete medical device products, including definition and control of interfaces, system behavior, performance requirements, and subsystem interactions.
• Creates product designs and documentation used to substantiate those devices (i.e. risk assessments, verification/validation activities, design review documentation, etc.)
• Maintains all documentation necessary for a Design History File (DHF), including Design Input Documents, Design Validation Plans/Reports, Test Protocols/Reports, and Design Input/Output Matrix.
• Collaborate with Clinical, Product Management, Systems Engineering, Quality, Regulatory Affairs, Manufacturing, Operations, and Program Management to translate clinical and business objectives into product requirements, technical architectures, and executable development plans.
• Support technical design and capability throughout the medical device development lifecycle, ensuring compliance with applicable FDA, MDR, IEC, and ISO requirements.
• Identify technical risks across hardware, software, instrumentation, algorithms, manufacturing, and clinical workflows and develop effective mitigation strategies.
• Support verification, validation, usability engineering, and design transfer activities to ensure safe and effective products.

• Expected areas of technical scope includes augmented reality, orthopedic navigation systems and / or and integration of orthopedic navigation with robotic systems for knee and shoulder applications.
• Influences technology strategy, system architecture, and engineering direction across software, hardware, algorithms, instrumentation and visualization.
• Serves as the primary technical authority for multidisciplinary product development efforts.

• Bachelor's degree in Engineering (Computer Science, Software Engineering, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, etc.) or related technical discipline; Master's degree preferred.
• Minimum 8 years of experience developing complex medical devices or related technology products.
• Demonstrated experience leading multidisciplinary engineering teams.
• Strong systems engineering background integrating software, electronics, mechanical systems, and algorithms.
• Experience with medical device design controls and product development processes.
• Strong understanding of system architecture, technical risk management, verification and validation, and product lifecycle management.
• Excellent analytical, organizational, leadership, and communication skills.
• Strong written and verbal communication skills with the ability to influence technical and business stakeholders.
• Most possess or be able to obtain and maintain a valid passport to support international business travel, as required by the role.

• Experience developing orthopedic navigation, visualization, or image-guided surgical systems.
• Experience with computer vision, sensor fusion, inertial navigation, optical tracking, or image processing.
• Experience with mechatronics, automation, or advanced control systems.
• Experience developing orthopedic instrumentation or capital medical equipment.
• Familiarity with standards applied to design tasks like IEC 62304, ISO 13485, ISO 14971, IEC 60601 series, FDA Design Controls, and EU MDR.
• Experience bringing medical devices from concept through commercialization.

• Technical Lead: Provides clear technical direction while driving engineering excellence and innovation.
• Strategic Thinking: Aligns technology decisions with business objectives and long-term product strategy.
• Collaboration & Influence: Builds strong relationships and effectively influences cross-functional teams without direct authority.
• Execution Excellence: Delivers high-quality technical solutions while balancing timelines, quality, and business priorities.
• Problem Solving: Analyzes complex technical challenges and develops scalable, practical solutions.
• Communication: Clearly communicates technical concepts, project status, risks, and recommendations to technical and non-technical audiences.

Travel Requirements

Minimal to moderate travel as business needs require.

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We offer a comprehensive benefits package that includes:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Spending and Savings Accounts
• 401(k) Plan
• Vacation, Sick Leave, and Holidays
• Income Protection Plans
• Discounted Insurance Rates
• Legal Services

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EQUAL EMPLOYMENT OPPORTUNITY

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.