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Principal Validation and Verification Test Engineer

Hudson, MA

Posted: 05/13/2022 Industry: Engineering and Technical Job Number: 14395

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

 

Title: principal Validation and Verification Test Engineer

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration: Perm
  • Pay rate: $120-145k
  • Job Location:   Hudson, MA
  • Job#: bh14395

Principal Validation and Verification Test 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.
  • 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.

Knowledge/Educational Requirements

  • 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

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