Sr Test Engineer
Tewksbury , MA 01810 US
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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
ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
- 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
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