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Component Owner 4

  • Location

    Norwood, United States

  • Sector:

    Business Professional

  • Job type:

    Contract

  • Contact:

    Sonu Chouhan

  • Job ref:

    23558

  • Published:

    about 2 months ago

  • Expiry date:

    2021-04-14

Ideal candidate will have a BSME, 5-7+ years, IVD, diagnostics, microfluidics, optics, and blood test product experience. This position will perform R&D and product development activities, which may also include the management of external product development firms. This is a hands-on position in a fast-paced environment that requires an experienced engineer capable of learning quickly. Need someone that has a good electro-mechanical experience to help to complete the prototype readiness for this phase.

Responsibilities:

This position will perform R&D and product development activities, which may also include the management of external product development firms. This is a hands-on position in a fast-paced environment that requires an experienced engineer capable of learning quickly.

Responsibilities include:

  • Support internal team in troubleshooting electro-mechanic systems with focus on root cause analysis and the development of solutions
  • Act as primary technical contact for third party product development firm, which will include managing multi-organizational deadlines, documentation and technology transfer
  • Minimal supervision with wide latitude for independent judgement
  • Set direction within the scope of multiple moderate projects or portions of major projects
  • Execute work independently or as part of a team
  • May train and supervise Junior Engineer
  • Assist with the intellectual property development including IP strategy and filing

Requirements:

  • B.S. or M.S. in Mechanical engineering with 5-7+ or more years of experience. Preferably in an FDA regulated Environment
  • Experience with IVD or Life Science hardware development used for processing and analyzing blood preferred
  • Experience with blood or blood biproducts filtration and handling
  • Advanced Knowledge of CAD/CAM and rapid prototyping process (SolidWorks)
  • Understanding/experience in injection molded part design and processes
  • Understanding/experience in plastic welding and bonding processes
  • Familiarity with common blood and urine analysis techniques, including flow cytometry, coulter, ISE, spectrophotometry, turbidimetry, ELISA, and PCR.
  • Materials selection, biocompatibility, sterilization experience
  • Understanding of system design, electronics, mechanical, disposables, and software integration
  • Design of experiments knowledge
  • Product development methodologies, design & implementation
  • Ability to develop plans and schedules for a complex project and lead them through completion
  • Strong organizational and communication skills with the ability to work with directly with a broad range of clinical, scientific, engineering, regulatory and business teams in a multiorganizational setting

This position requires a highly motivated individual with a strong work ethic. The environment is typical of most Series A start-up companies, and the ideal candidate should be willing to take on increasing responsibilities, including the management of a growing engineering team.