Engineer/Senior Systems Engineer

Support the ongoing lifecycle of released products, ensuring compliance with safety, quality, and regulatory standards

Maintain system requirements, risk management f iles , and design documentation

Collaborate with cross-functional teams (Engineering, Quality, Regulatory, Manufacturing) to evaluate and implement product changes

Support investigation of field issues and customer feedback using structured root cause analysis

Contribute to post-market surveillance and risk management activities (e.g., Hazard analysis, safety risk assessments )

Support verification & validation and ensure end-to-end traceability

Participate in design reviews, audits, and continuous improvement initiatives

Lead projects or workstreams independently

Mentor junior engineers and drive best practices

Degree in Engineering (Biomedical, Mechanical, Materials, Chemical or similar)

3–5 years (Engineer) or 5–8 years (Senior) experience

Experience in a regulated industry (medical devices, healthcare preferred)

Knowledge of design controls, risk management, and product lifecycle processes