R&D Engineer – Medical Devices / Design Transfer

Veriipro; Raynham (MA); On-site; USD 85,000 - 115,000; Full time

Job summary

Veriipro is seeking an experienced R&D Engineer to support mechanical medical device development and lifecycle activities. The role involves leading or assisting manufacturing/site transfers and maintaining engineering docs per design controls and change management.

You will verify, validate, and document engineering work, prepare technical reports and project plans, and drive projects from planning to completion while managing timelines and risks in a regulated environment.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• 3–5 years R&D experience in medical devices.
• Experience with design controls and change management.
• Experience with manufacturing/site transfer activities.
• Ability to work independently with minimal supervision.

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 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 risks.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, and Operations to resolve 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 regulatory and quality compliance.
• Independently identify issues, develop solutions, and drive projects to completion.

Skills

R&D Engineering

Medical devices

Site transfer

Design controls

Project ownership

Independent work

Regulated environment

Windchill PLM

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

Windchill PLM

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.