Test Engineer

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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Test Engineer

  • Specialty:

    Engineering
  • Title:

    Test Engineer
    • City:

      Waltham
    • State:

      MA
    • Zip Code:

      02452
  • Start date:

    07-13-2020
  • Status:

    Closed
  • Assignment Type:

    Contract
  • Job Id:

    53789

Description

We are looking for a Test Engineer to handle the preparation, execution and documentation of testing activities in support of new product introductions. Starting from a database of requirements that encompasses the product platforms, the Lab Test Engineer will develop test methods, fixtures and procedures to first characterize and subsequently formally verify product performance. Test activities in the lab will be conducted at all levels, from component to sub-assembly to full system, and includes verification of performance and validation of user requirements, in our on-site test lab. The Lab Test Engineer owns formal verification activities including test equipment control, test equipment set-up and use, test protocol development, test execution, data analysis and report generation.  
 
Responsibilities:

  • Work on-site in our test lab, maintaining test equipment and test set-ups
  • Write detailed test procedures that evaluate product and systems against documented mechanical, electrical and software requirements
  • Develop test methods and fixtures for all development testing including verification while collaborating with development teams or outside resources
  •  Execute the verification and validation of product design including requirements analysis, traceability, and testability assessment
  • Prepare and execute test method and fixture qualifications. Fixtures may be mechanical, electromechanical, pneumatic, with or without software controls
  • Perform on-site test case execution following established test protocols and test methods
  • Maintain and control test execution records using good lab practices
  • Automate tests where applicable
  • Escalate, when appropriate, cross-funtional support issues on projects to the Project Manager or to functional leadership
  • Actively evaluate projects for opportunities to improve performance
  • Continuously monitor risk and mitigate as appropriate 

Requirements: 

  • Bachelor of Science degree, Associates Degree or 2-year technical degree.
  • Minimum of 4 years of experience in conducting verification and validation of electro/mechanical systems in a regulated industry.
  • Medical device development experience along with a solid working knowledge of FDA Quality System Regulations and ISO 13485, and IEC 60601 is highly preferred 
  • Possess the ability to analyze requirements and develop a risk-based approach to testing
  • Hands-on experience with measurement equipment, preferably including mass flow controllers and other pneumatic elements
  • Familiarity with requirement management tools leading to generation of complete traceability matrices (i.e. Doors, Jama, Test Track, etc.)
  • Familiarity with main standards applicable to the development of medical devices (i.e. IEC 60601-1, ISO 10993, etc.) • Knowledge of statistical techniques for experimental design and data analyses • Strong design control and documentation skills
  • Good technical writing skills, including development of test methods, protocols, reports
  • Proficient computer skills with applicable software packages (e.g. Microsoft Office, Microsoft Project, Microsoft Power Point, etc.) and test data analysis software packages (JMP, Minitab, ReliaSoft, and/or Python)
  • Good communication skills
  • Able to learn new technologies
  • Able to work independently in a test lab and in a team environment
  •  Experience with respiratory equipment is a plus
  •  Excellent problem-solving skills 

 
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