Forward Deployed Engineer embedded with enterprise clients at WRITER, optimizing AI deployment while serving as a technical liaison. Requires in - depth AI expertise and software development skills.
MA
Onsite System Verification and Validation Engineer
Posted 1 hour ago
About the role
- System-level V&V Engineer ensuring compliance and traceability for medical device engineering. Collaborate and execute plans and reports while maintaining documentation under ISO standards.
Responsibilities
- Execute system-level V&V
- Ensure requirements traceability, compliance, and objective evidence for design releases and sustaining changes
- Develop and execute V&V Plans, Protocols, and Reports
- Maintain requirements traceability and DHF documentation ( Design History File)
- Perform hardware/software/wet-lab tests; Ensure compliance with ISO 13485 standards
- Communicate status and present evidence in reviews
Requirements
- 7-10 years in system-level V&V for IVD/medical devices or complex electromechanical systems
- Experience in test automation
- Hands-on protocol design and execution in regulated environments
- Bachelor’s / master’s degree in engineering (Electrical, Biomedical, Mechanical, Software)
- Preferred: Wet-lab workflow knowledge; understanding of sample handling and reagents.
Benefits
- Flexible work
- Healthcare including dental, vision, mental health, and well-being programs
- Financial well-being programs such as 401(k) and Employee Share Ownership Plan
- Paid time off and paid holidays
- Paid parental leave
- Family building benefits like adoption assistance, surrogacy, and cryopreservation
- Social well-being benefits like subsidized back-up child/elder care and tutoring
- Mentoring, coaching and learning programs
- Employee Resource Groups
- Disaster Relief
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