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Title:  Test Engineer II

Requisition Number: 
Description: 

 

Enable Injections is made up of a team passionate about working together to make people’s lives better. We develop, manufacture, and support the enFuse®, a platform of wearable infusion devices designed to enable subcutaneous self-administration of high-volume therapeutics. Enable employees are technology experts focused on an exceptional patient experience in collaboration with our biopharma partners.

 

PURPOSE OF POSITION:  The Test Engineer II is responsible for developing methods, conducting tests, analyzing results, and producing documentation to demonstrate compliance to quality system requirements.  The Test Engineer is responsible for the timely approval of protocols and closure of test reports to ensure the lab schedule is maintained.

 

QUALIFICATIONS

 

 

 

Required:

 

  • Bachelor's degree or higher in Mechanical or Biomedical Engineering from an accredited university.
  • A minimum of 2 years’ experience in a testing lab environment with knowledge of standard methods for mechanical testing.

 

Preferred:

  • Experience working for a medical device manufacturer.

 

Skills & Competencies:

 

  • Excellent verbal communication, technical writing, and presentation skills.
  • Strong analytical skills and creative problem-solving skills.
  • Expertise in custom test method development and validation.
  • Meticulous attention to detail.
  • Ability to effectively plan and manage priorities.
  • Contribute to a dynamic start-up environment.

RESPONSIBILITIES:

 

  • Work closely with product development, manufacturing engineering, and quality engineering to ensure test methods are adequately verifying requirements.
  • Write detailed test protocols and reports for regulatory submission.
  • Lead technical presentations to share results and findings with other engineers.
  • Conduct root cause analysis on test failures and manufacturing defects.
  • Analyze test results utilizing statistical methods.
  • Collaborate with test technicians to run feasibility and verification tests.
  • Participate in design reviews and utilize experience to mitigate design and process risks.
  • Identify areas of inefficiency and implement organization initiatives such as Lean or 5S.
  • Adhere to company procedures, industry regulations and customer requirements.
  • Identify lab needs and manage procurement for equipment and supplies.

 

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.