R&D Engineer – Medical Devices / Design Transfer

Key Responsibilities

• Support R&D engineering and product lifecycle activities for mechanical medical devices.
• Lead or support manufacturing and site transfer activities, including product movement between manufacturing facilities.
• Develop and maintain engineering documentation in accordance with design control and change management processes.
• Support design verification, validation, and engineering validation activities.
• Prepare and maintain technical reports, project plans, validation documentation, and engineering change documentation.
• Drive engineering projects from planning through implementation while managing timelines, deliverables, and technical risks.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, and Operations to resolve technical and product-related issues.
• Support engineering changes, product improvements, and lifecycle management activities.
• Maintain product and engineering information within PLM/document control systems.
• Apply appropriate engineering practices and ensure compliance with applicable regulatory and quality requirements.
• Independently identify issues, develop solutions, influence stakeholders, and drive projects to completion.

Required Qualifications & Skills

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 3–5 years of R&D Engineering experience, preferably within the medical device industry.
• Experience supporting mechanical medical devices or regulated products.
• Strong understanding of design controls, change management, engineering documentation, and validation.
• Hands-on experience with manufacturing transfer or site transfer activities.
• Experience working in a regulated product development environment.
• Strong project ownership with the ability to work independently and drive deliverables with minimal supervision.
• Excellent problem-solving, communication, collaboration, and stakeholder-management skills.

Preferred Qualifications

• Experience with Windchill PLM or other PLM/document control systems.
• Experience working in an FDA-regulated medical device environment.
• Experience preparing technical reports, project plans, validation documentation, CCR/CCP documentation, and related engineering deliverables.
• Experience supporting product transfers between manufacturing facilities.
• Experience collaborating with Quality, Regulatory Affairs, Manufacturing, and Operations teams.
• Strong understanding of medical device product lifecycle and engineering change processes.

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