System Engineer
Optomi, in partnership with a premier client in the medical device industry, is seeking a Systems Engineer to support a high-priority design control, documentation remediation, and regulatory initiative. This role will work closely with R&D, Quality, Regulatory, and international engineering teams to evaluate existing product-development documentation, identify gaps, strengthen requirements traceability, and help ensure development evidence is complete, compliant, and aligned with U.S. medical device expectations. The ideal candidate will bring hands-on experience across systems engineering, design controls, DHF documentation, requirements management, risk management, verification and validation, and cross-functional medical device development. This is a 12+ month contract (with intention to convert to full-time) and fully remote (must be based within the US). The Right Candidate Will Have Direct experience working within the medical device industry Experience with systems engineering, design controls, DHF documentation, and product-development processes Hands-on experience with requirements management, requirements traceability, design inputs/outputs, risk documentation, and V&V evidence Experience identifying documentation gaps and supporting remediation efforts for legacy or existing products Ability to work across software, hardware, electrical, and system-level documentation Strong understanding of FDA-regulated product development and applicable medical device quality requirements Experience working cross-functionally with R&D, Quality, Regulatory, Project Management, and other technical teams Comfort working in an environment where processes and systems may still be evolving Strong communication skills and the ability to work effectively with international engineering teams Experience with requirements-management or lifecycle tools such as Polarion, DOORS, DOORS Next Generation, Jama, PTC, Azure DevOps, or similar platforms Korean language skills are a strong nice-to-have due to collaboration with an international parent organization
What You Will Do
Review existing product-development and design-control documentation to identify technical and compliance gaps Support DHF remediation and strengthen alignment across user needs, system requirements, subsystem requirements, design outputs, risk controls, verification, validation, and traceability Evaluate requirements and supporting evidence for completeness, consistency, and compliance Partner with engineering teams to resolve missing, incomplete, or inconsistent development documentation Support remediation activities tied to FDA submission and regulatory readiness Help establish and improve systems engineering and requirements-management processes Work closely with R&D, Quality, Regulatory, and Project Management to drive documentation issues through resolution Collaborate with international engineering teams to gather technical information and align development evidence with U.S. regulatory expectations Maintain a hands-on role in requirements, traceability, V&V documentation, risk documentation, and other design-control deliverables Support continued growth of internal systems engineering capabilities across the organization