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