Senior Mechanical Engineer - IVD, microfluidics, optics, automated systems, medical device (Lexington)

Compensation

: $96,010.00 - $138,950.00 /year *

Employment Type

: Full-Time

Industry

: Engineering



Job Description

InnoTECH Staffing is looking to hire a permanent Senior Mechanical Engineer with medical device for a client in the Waltham, MA area.

Ideal candidate will have a BSME, 5-7+ years, IVD, diagnostics, microfluidics, optics, automated pipette systems or 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 start-up 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. This is the short term goal. then... it will develop into a product R&D position. We will need to complete the R&D development of key technology of the system as part of finishing the system. The field for the R&D piece is on disposable blood filtration.

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 start-up 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.

Salary up to $130K


Associated topics: aerodynamic, assembly, automotive, boiler, chassis, design, fluid, thermal, turbine, turbomachinery * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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