Systems Design/Development Engineer (Medical Device)

Our client is a global leader in musculoskeletal healthcare. They design, manufacture and market orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products. Their products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Alongside some of the world's top healthcare professionals, they help deliver new possibilities to patients.

Looking for a Systems Design / Product Development Engineer to support development of a software-based medical device (SaMD). The ideal candidate has a solid foundation in systems engineering and product development within a regulated environment, with hands-on experience drafting and maintaining design history file (DHF) content. This role plays a key part in refining and updating existing product documentation and ensuring continued regulatory alignment as the product moves through its lifecycle.

Responsibilities

Draft and maintain DHF content including user needs, system/design requirements, software requirement specifications, design inputs, traceability matrices, and risk documentation.

Support risk analysis activities (e.g. FMEAs) and contribute to usability engineering activities.

Support V&V activities including drafting, execution and creation of test cases, reports and other testing artifacts.

Collaborate cross-functionally with R&D, QA, Clinical, and Regulatory to translate technical information across stakeholder groups

5+ years of experience in systems design/product development within a multi- disciplinary organization.

Demonstrated experience with SaMD development and regulatory documentation.

Working knowledge of ISO 14971; familiarity with ISO62304 and IEC 62366 preferred. Experience drafting DHF artifacts (user needs, requirements, traceability matrices, risk files).

Experience in a regulated, compliance-driven environment (FDA/QMS).

Strong analytical skills and sound technical judgment.

Excellent written and verbal communication skills, with ability to work effectively with internal and external collaborators.

Experience with Codebeamer, JIRA, or similar requirements/traceability tooling., Bachelor's degree in Engineering or a related science field; Biomedical Engineering preferred.

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance