Systems Engineer

Responsibilities

• Gather and translate user, business, and cross‑functional stakeholder needs into system and product requirements.
• Develop requirements strategies, traceability, verification methods, and validation plans.
• Author and maintain technical documentation in compliance with medical device design control requirements.
• Identify system interfaces, dependencies, risks, and gaps in requirements or verification evidence.
• Lead and support verification & validation (V&V) activities.
• Partner with Regulatory, Marketing, Risk Management, Software, Electrical, and Mechanical Engineering teams.
• Support Design History Files (DHFs), requirements traceability, and design reviews.
• Drive risk assessments, hazard analysis, and mitigation activities throughout the product lifecycle.

Qualifications

• 3–5 years of Systems Engineering experience (open to one more senior candidate).
• Experience translating user needs into system requirements.
• Strong understanding of requirements development, traceability, verification, and validation.
• Experience identifying system interfaces, dependencies, and technical risks.
• Strong technical writing and documentation skills.
• Understanding of the full product development lifecycle.
• Experience working in regulated environments and cross‑functional teams.