Norwood, United States
5 months ago
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.
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.
- 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
- 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.