Lead R&D Engineer, Sustaining Engineering

Summary

The Lead R&D Engineer is a senior individual contributor within Research and Development who provides technical leadership in the identification, design, development, and commercialization of medical devices. The role applies strong engineering expertise to progress product concepts from early clinical need and technology exploration through prototype development, verification, validation, and support of commercialization. Operating with a high degree of autonomy, the Lead R&D Engineer collaborates extensively with cross‑functional partners across R&D, Quality, Regulatory, Manufacturing, and Marketing to deliver innovative, compliant, and customer‑focused solutions that support business growth.

• Represent Research and Development on cross‑functional product development and commercialization teams.
• Translate basic clinical and customer needs into device concepts, designs, and prototypes while ensuring consideration of human factors, usability, and regulatory requirements.
• Research, evaluate, and apply new materials, technologies, and processes to support development of new and existing product platforms.
• Lead or support concept development, feasibility assessments, prototyping, and iterative design refinement.
• Source, select, and evaluate materials, components, and supplier technologies for suitability and performance.
• Develop product and component specifications to ensure consistent performance aligned to customer and business requirements.
• Develop and execute test methods to characterize and measure product performance, stability, and functionality.
• Plan, perform, and document design verification and design validation activities in compliance with design control requirements.
• Provide technical R&D support to Global Marketing, Regulatory Affairs, Engineering, Manufacturing, and other functions as required.
• Manage assigned project schedules, conduct technical and project risk analyses, and support timely completion of project deliverables.
• Prepare and maintain technical documentation including reports, drawings, specifications, and analysis summaries.
• Support intellectual property activities, including collaboration with patent counsel on patentability and infringement assessments.
• Apply advanced engineering knowledge to solve complex and often ambiguous technical problems.
• Lead or significantly contribute to technical execution of projects with minimal supervision.
• Integrate regulatory, quality, and design control requirements into development activities.
• Analyze experimental and performance data using appropriate analytical and statistical methods.
• Communicate technical information clearly and effectively to cross‑functional stakeholders at multiple organizational levels.
• Collaborate effectively within multidisciplinary teams and contribute to a culture of innovation, accountability, and continuous improvement.

• Translating technical findings into business‑relevant insights.
• Collaborate with cross‑functional teams (Regulatory, Marketing, Market Access).
• Ensuring adherence to regulatory standards (e.g., EU MDR, FDA).
• Maintain quality systems and compliance with regulatory standards.

• Bachelor’s Degree with 8–12 years of related experience.

• Honours Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Design Engineering, or a related engineering discipline required.
• Typically requires 8–12 years of relevant industry experience, preferably within medical devices or other regulated product development environments.
• Demonstrated experience working within medical device quality systems, including design controls and applicable regulatory standards.
• Proven experience in product design, prototype development, and execution of verification and validation activities.
• Working knowledge of project execution principles, including planning, risk management, and cross‑functional coordination.
• Proficiency with common engineering tools and software, including 3D CAD and standard business applications.
• Master’s degree or PhD in an engineering or related technical discipline.
• Experience leading or coordinating…