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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.
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• 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

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