Medical Device Design Engineer

Our client, a leading medical device organization, is seeking a Medical Device Design Engineer to support engineering documentation and design control activities. This individual will work closely with an established engineering team to prepare technical documentation, complete assigned deliverables, and support ongoing medical device development initiatives. The ideal candidate has a background in mechanical engineering, biomedical engineering, or medical device design quality, with a foundational understanding of medical device design controls and regulatory requirements. Candidates with relevant internship or co-op experience will also be considered.

Responsibilities

• Partner closely with engineering team members to support medical device design and development activities.
• Create, update, and maintain technical documentation, design control records, reports, and other engineering deliverables.
• Support documentation activities in accordance with FDA 21 CFR, ISO 13485, and ISO 14971 requirements.
• Prepare and organize engineering reports, design history documentation, and supporting technical materials.
• Utilize Microsoft Word, Excel, PowerPoint, and Windchill to develop, maintain, and manage project documentation.
• Execute assigned engineering tasks and documentation deliverables under the guidance of experienced engineers.
• Collaborate with cross-functional teams to ensure documentation is accurate, complete, and aligned with project requirements.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline preferred.
• Experience in the medical device industry, including relevant internships or co-op assignments.
• Foundational understanding of medical device design controls, documentation processes, and regulatory standards, including FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Experience creating or maintaining engineering documentation, technical reports, or design control deliverables.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Familiarity with Windchill or a similar product lifecycle management (PLM) system preferred.
• Experience in medical device design quality may also be considered, particularly with hands-on documentation development.
• Strong attention to detail, organizational skills, and ability to complete assigned tasks while collaborating with engineering teams.
• Ability to work onsite in Raynham, MA, at least weekly as part of a hybrid schedule.

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