Duration: 6 months (extension possible)
Start Date: ASAP
Job Description:
The Systems Engineering/Design Assurance contractor will support the development and sustaining engineering of in vitro diagnostic systems, ensuring compliance with FDA & IVDR design controls. Responsibilities include updating/reviewing product documentation, defining requirements, maintaining trace matrices, supporting labeling updates, contributing to risk assessments, and ensuring alignment with quality plans. Must have 3–5 years of requirements management/writing, IVD and medical device experience, strong problem-solving skills, and familiarity with risk management processes.
Key Responsibilities:
- Update, review, and maintain product design and regulatory documentation (user needs, system/subsystem requirements, trace matrices, labeling)
- Support IVDR-related plans/reports, verification plans, test protocols, and risk assessments
- Collaborate with cross-functional teams to drive deliverables and meet project timelines
- Manage and monitor execution of R&D quality plans and address non-conformances
- Contribute to sustaining engineering and design change projects
Must-Have Qualifications:
- 3–5 years of requirements management and writing experience
- Experience in in vitro diagnostics (IVD) and medical device design controls
- Strong problem-solving and critical thinking skills
- Familiarity with risk management processes and integration into product development
- Team-oriented with excellent communication skills
Nice-to-Have Skills:
- Experience with IBM DOORs and Agile tools
- Project coordination experience
- Verification & validation process knowledge
- Trace matrices expertise
MA (Hybrid): SYS Team Contractor Systems Engineer (238033)
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