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Sr Test Engineer

Tewksbury , MA

Posted: 05/03/2023 Industry: Engineering and Technical Job Number: 15594

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: Sr test Engineer
Hiring Organization: Connexion Systems & Engineering

  • Duration: Perm
  • Pay rate: $130-145K
  • Job Location: Tewksbury, MA
  • Job# 15594

  • Lead test engineering activities for new development projects.
  • Responsible for conducting feasibility and verifications testing including system, environmental, usability, biocompatibility, reliability, sterility, and safety testing.
  • Manage requirements and ensure traceability to all protocols and specifications.
  • Write verification and validation protocols based upon requirements and user needs.
  • Design and validate new test methods and test fixtures.
  • Release all test protocol and fixture documentation using change order process.
  • Test prototypes using laboratory equipment and document in DHF.
  • Execute V&V test protocols and write verification and validation reports.
  • Fabricate prototypes with assistance from technical support team (Machine Shop, Technicians and Designers) and suppliers.
  • Assist in software test validation, FMEAs, and Design Reviews. 
  • Maintain test equipment to ensure calibration and preventative maintenance are performed.
  • Coordinate test activities with external testing partners.
  • At least 8 years of experience with 2 years in a lead role for performing verification and validation testing on Class II or III medical devices.
  • Strong understanding of medical device development processes including experience with FDA CFR 820 and ISO 13485 regulations
  • Must be able to work in a fast paced, high energy, collaborative team that possesses a strong sense of urgency.
  • Strong problem-solving skills with the ability to identify root cause for test failure.
  • Experience applying statistical techniques to determine sample sizes based on risk
  • Ability to work independently with high competency and little guidance
  • Strong written and verbal communication skills are required.
  • Ability to use laboratory equipment, hand and power tools.
  • Proficiency with Minitab and a Six Sigma Green Belt is strongly desired.
  • Basic knowledge using Solidworks 3D modeling is highly desired.
  • Ability to be onsite 5 days per week and lift 25lbs.
  • BS in Mechanical, Electrical or Biomedical Engineering

  • Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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