Sr. Systems Verification Engineer
Marlborough, MA 01778 US
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Title: Systems Verification Engineer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: Perm
- Pay rate: $105-135k
- Job Location: Hudson, MA
- Job#: bh14394
Systems Verification Engineer
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.
- Own and support system verification, as a core team member and leader
- Provide hands-on engineering support for system integration, system protocol definition, feature integration and verification of laser systems.
- Provide test support related to design margin testing, operational environmental, packaged testing and performance testing
- Lead alpha and beta testing including test definition, test plan creation, test protocol definition, site support and report creation.
- Ability to create and execute verification test plans, protocols, reports and test procedures to meet system and low level design 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.
- Provide support to clinic and usability lead for user preference test and usability tests
- Support both alpha and beta tests
- Support in preparation for medical compliance tests
- Provide product traceability related to PRD, SRS and HRD through the requirements management tools, ensuing that all risks are addressed with safe and effective mitigations.
- Utilize Defect Tracking System, report and/or resolve product issues.
- Ability to analyze field issues and create test cases to stimulate system (Fault Integration)
- Degree in Biomedical/Electrical/Computer science or similar related field.
- Ability to create robust documentation and having a strong attention to detail
- 5+ years of experience in Verification 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 60601, IEC62304, IEC62366, HE74, HE75
- Familiarity with SW and System automated test tools – strong advantage
- Strong Analytical and problem-solving skills
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