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Job description
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.
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.