Test Engineer II

7 days ago

North Haven, United States Planet Pharma Full time

Top 3 technical skills that are required for the role:

  1. Analytical with strong problem-solving abilities
  2. Proficient in technical writing to convey clear and concise instructions to other functional teams
  3. Experience with complex, electromechanical, software controlled and/or robotic systems including mechanical, electrical, and software components



SUMMARY OF POSITION:

This company is engaged in medical technology. A new product development team for the Surgical Innovation business in the Minimally Invasive Therapies Group (MITG) Business Unit is seeking a Test Engineer. The Test Engineer shall support test activities to best meet the project’s requirements. This position will be a part of a R&D Test Engineering Team and will interface with cross-functional team members.

Essential Responsibilities:

  • Work in a multi-disciplinary team developing test methods for a complex, electro-mechanical system
  • Plan, execute and document system and sub-system tests
  • Document tests via test methods and reports
  • Validate Test Methods and support test results validation reports
  • File documentation, software, or drawings in depository system
  • Create quality and safety related documentation to support validity of test and test fixture.
  • Support test team by executing verification testing
  • Support hardware and electrical engineers with test fixtures
  • Train other team members on various testing activities
  • Communicate test related activities and results with multi-disciplinary team members
  • Developing test methods for design verification
  • Designing and Analyzing test method validation(MSA, Gage R&R, etc) studies
  • Investigating test failures and identifying root cause
  • Analyzing test data using appropriate statistical tools
  • Writing Engineering Reports as needed
  • Reviewing requirements for testability
  • Developing overall verification strategy against requirements
  • Estimating required sample sizes or developing sample size justifications
  • Writing Design Verification Protocols and Reports

Education & Experience:

  • A Bachelor degree in electrical, mechanical, or biomedical engineering is required.
  • One or more years’ experience in medical device product development or equivalent is required.
  • Solid understanding of engineering fundamentals and proven hands-on electronic/mechanical skills.
  • One or more years’ demonstrated experience and expertise with product testing, test equipment, analysis methodologies and test documentation is preferred.
  • Familiarity with standard test equipment such as Instron, imaging scopes, force gauges, data loggers, and CMM is preferred.
  • Experience in testing electro-mechanical systems is a plus.

Skills/Abilities:

  • Demonstrated ability to perform as a contributing member of cross functional teams, including quality, electronic, and mechanical engineers.
  • Analytical with strong problem-solving abilities and creative resolution skills
  • Proficient in Microsoft office programs including Excel and Word
  • Organize and be able to prioritize workload, meet multiple deadlines simultaneously in a fast paced environment
  • Strong communication skills [oral and written] including listening; and ability to maintain clear project status and interlocks with internal project teams and external test agencies
  • Strong interpersonal skills: function as a “team player” and work constructively and cooperatively with all team members in the best interests of the program.
  • Direct involvement with Design Verification of medical devices
  • Experience with complex, eletromechanical and/or software controlled and/or robotic systems including mechanical, electrical, and software components
  • Proficient in technical writing to convey clear and concise instructions to other functional teams

Working Conditions:

  • Work usually performed in an office setting, laboratory, and/or surgical laboratory.
  • Travel – none

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