Sr Systems Verification Engineer (Contract)
Hudson, MA 01778 US
Title: Sr Systems Verification Engineer
Hiring Organization: Connexion Systems & Engineering
- Duration: Temp
- Pay rate: $80-95/hr
- Job Location: Hudson, MA
- Job# 15740
The Senior System Verification Engineer is responsible for verifying and validating multi-disciplinary complex energy based (Laser / RF / HIFU) medical aesthetic devices.
Essential Job Functions
- The ideal candidate possesses the ability to work both independently and as part of a team, with strong written and verbal communication skills. The person must be organized, detail oriented. The candidate ensures quality-engineering work and collaborates with experts in various disciplines (DQA, NPI, Sustain and Regulatory groups) in the integration, test, and evaluation of laser systems.
- Provide hands-on engineering support for development, integration, and verification of laser systems.
- Ability to develop and execute V&V test plans, protocols, reports and test procedures to meet product requirements in accordance with internal company processes and international medical regulations.
- Verification planning, assembly, test preparation, and maintenance of engineering prototype medical systems.
- Troubleshooting; optic, mechanic, hardware and software; test data analysis.
- Support in preparation for medical compliance tests
- Provide input into completion of product traceability analysis from marketing and product requirements through product risk mappings in relation to verification specifications.
- Uses Defect Tracking System, report and/or resolve product issues.
- Degree in Electrical / Software Engineering or similar related field.
- Ability to create robust documentation and having a strong attention to detail
- 5+ years of experience in Verification and Validation under Medical Device Regulations
- Experience in an FDA regulated environment that meet internal quality requirements and regulatory standards for Class II medical devices
- Familiarity with FDA 21 DFR 820.30, ISO 14791, IEC 62304, IEC 60601
- Familiarity with SW and System automated test tools – strong advantage
- Strong Analytical and problem-solving skills
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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