Position Description:

‍The Senior II Test Engineer is responsible for delivering high quality medical products to our customers by driving critical projects from concept through commercialization. The Test Engineer will modify existing test methods, create new test methods, and validate new and existing test methods.  Early in the development cycle, the position will also be responsible for building and testing prototypes that are disposable, reusable, and capital. Success in this position relies heavily on the development and validation of the most difficult test methods with limited supervision. Due to the fast-paced nature of the work environment, success in this role requires the candidate to be in the office most days. This role will report directly to the Director of Mechanical Engineering and work on projects with cross-functional impact and visibility.

‍Principal Responsibilities:

‍The Test Engineer is a key position in the R&D organization. Responsibilities include:

  • Collaborate with key stakeholders to define the scope of testing, milestones, and deliverables to support critical business objectives
  • Plan and complete multi-factor design of experiments (DOE) using statistical software
  • Simultaneously develop both complex test methods and less complex test methods
  • Complete test method validations (TMV) based on business need and risk index
  • Train operators to test methods and create training effectiveness quizzes
  • Build, test, and evaluate electro-mechanical prototypes
  • Design, develop, document, and qualify numerous test fixtures using SolidWorks
  • Facilitate the use of 3D printers and outside machine shops to fabricate test fixtures
  • Write complex technical reports based on laboratory testing
  • Work cooperatively with quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all job responsibilities and duties.

‍Required Education, Experience, and Qualifications:

  • B.S degree in Mechanical Engineering or Biomedical Engineering from ABET accredited school
  • 5+ years of product development or test engineering experience
  • Medical device experience (majority of experience)
  • Developing test methods (improving legacy test methods and new test methods)
  • History of completing multiple Test Method Validations (TMV) based on product specifications
  • Working with the R&D engineering team to build and test prototypes
  • SolidWorks experience design, building, documenting, and qualifying fixtures for test methods
  • Good lab skills (keeps lab notebook, soldering, assembly, light machine shop work, 3D printing, etc.)
  • Good documentation skills (willing to complete multiple DCR’s per week)
  • Quick learner and can work autonomously from requirements

‍Required or Highly Desired Abilities and Attributes:

  • Works cross-functionally (Quality, Regulatory, Operations, Clinical, Marketing)
  • Strong electrical aptitude
  • Can create multiple different flow charts (e.g., process, swim lane, fishbone, fault tree, etc.)
  • Light programming experience (Excel, Arduino, Python, C++, etc.)
  • Data-driven, knowledge of advanced statistical concepts (e.g., GR&R, DOE, ANOVA, etc.)
  • Evidence of life-long learning (e.g., certifications, continuing education)

‍Working Conditions:

  • Light work, exerting up to 20 lbs. of force or less
  • Significant work pace and pressure due to deadlines
  • Stand or sit for 8 hours per day

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