Overview
On Site
$DOE
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 6+ Month(s)
Skills
system Engineer
Medical Device
Validation
Verification
V&V
Job Details
Hi,
Hope you are doing well.
My name is Rohen and I represent Vision InfoTech. Let me know if you're interested in the below position.
Role: System Engineer - V&V
Location: Andover, MA- Onsite
Job Type: Contract
Local candidates
LinkedIn profile
Medical device experience
About the job
Job Responsibilities
- Development and execution of system verification plans for medical devices, ensuring compliance with all relevant regulations (e.g., FDA, IEC 61010, ISO 14971, IEC 62304).
- Analyze system requirements and translate them into test protocols.
- Designs and implements test strategies and methodologies for various system components and functionalities across the Software, Hardware, and Systems levels.
- Develops and maintains automated test scripts using appropriate tools and languages (e.g., Python, C++, test frameworks).
- Performs manual testing and analysis to identify and document potential issues and defects.
- Coordinates with project management on verification timelines and readiness.
- Collaborates effectively with cross-functional teams (e.g., engineering, software, quality) to resolve identified issues and ensure timely closure.
- Participates in risk assessments and failure mode analysis (FMEA) to identify and mitigate potential risks.
- Maintains accurate and complete documentation of all verification activities, including test plans, reports, and defect tracking.
- Contributes to engineering discussions regarding design for testability, maintainability, and quality.
- Ensures alignment of internal and external customers.
- All other duties, as assigned.
Requirements
- Bachelors of Science degree BS in Biomedical/Mechanical Engineering or directly related scientific discipline, MS preferred.
- Applied understanding of mechanical, electromechanical, and systems design.
- 5+ years of experience in medical device system engineering.
- Solid understanding of medical device regulations and standards (e.g., FDA QSR, ISO 13485, IEC 60601).
- Proficiency in system-level design, requirements management, and architectural development.
- Excellent working knowledge of computer systems including MS Office Suites with advanced knowledge of Excel.
Thanks and Regards,
Rohen Singh
Talent Acquisition Specialist
VISION INFOTECH INC
Phone: .
Email:
368 Main Street, st#3, Melrose MA 02176
E-Verified Company
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