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