Test Engineer (19-00342) – MA – Newton

 Summary:
Lumicell is seeking a highly-motivated Test Engineer to work in a dynamic, fast-paced start-up environment. This is an exciting opportunity to join a company that has received excellent press and generated promising clinical data while still in its early development. The successful candidate must have a proven track-record in developing test procedures, establish test tool requirements, find and fix bugs in medical device systems, and record test results in support of engineering product development and continuous improvement initiatives. The successful candidate is a self-initiating and independent problem solver who integrates well into existing company processes.
The Test Engineer will be an integral part of the Product Development team and responsible for developing verification testing protocols, supervising and performing testing, report writing, and helping translate product requirements into clear technical specifications that can be tested against.
Responsibilities:

  • Design, author, and execute test plans and protocols to verify and validate (V&V) new medical device hardware and software products.
  • Create detailed Design of Experiments (DOE) to identify sources of variation in products and processes, and support root cause failure analysis.
  • Moderate test plan reviews, verification reviews, and participate in design reviews.
  • Design and administer debugging tools to conduct software and hardware failure analysis.
  • Analyze the functionality of prototype hardware and software systems and assist team in enhancing existing systems in lab or field environment to ensure product reliability and usability.
  • Show exceptional attention to detail and ability to effectively and accurately document test results.
  • Produce very clear, detailed reports of test plans and results for FDA submissions.
  • Provide technical support to technicians for various testing activities.
  • Confidently communicate and present findings to the team, other engineering disciplines, and senior management.

Qualifications:

  • BS in Biomedical, Mechanical, Optical, Electrical Engineering or closely related discipline.
  • Minimum of (3) years of experience in the test engineering and reliability field, working on
    medical devices in a regulated environment (510k, PMA). Experience with IEC-60601 a plus.
  • Confident and comfortable being involved in mechanical, electrical, optical, and software
    engineering projects.
  • Demonstrated understanding of statistical analysis concepts and methods.
  • Experience with medical imaging, fluorescence imaging and/or optoelectronics is highly desired.
    Critical Competencies for Success:

    • Excellent problem-solving, troubleshooting, and communication skills.
    • Detail oriented and highly organized.
    • Must be able to work independently and as part of a team, learn quickly, and take on
      responsibilities outside of this scope of work, as necessary.
    • Must have strong patient and user focus and design with patient outcomes in mind.
    • Must be resilient and focused with a knack for navigating complex and occasionally ambiguous
      environment.
      Supervisory Responsibility:
      This position does not currently have supervisory responsibilities over other managers.
      Work Environment:
      This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers, photocopiers and smartphones.
      Position Type/Expected Hours of Work:
      This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand.
      Travel:
      Some travel may be expected for this position including internal meetings, conference and or training events.
      EEO Statement:
      Lumicell is an equal opportunity employer.
      Other Duties:
      Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Source: Job Diva – Job Listing

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