Lead Mechanical Engineer

Qualifications:

BSME, 15+ years of working experience

Extensive experience in development of biotech instrumentation with a consumable/disposable component (one-use cartridge...etc.)

Strong familiarity of plastic injection molding process, knowledge of tooling design, materials, material properties, DFM

Demonstrated experience taking products through R&D and release to manufacturing

Experience executing and managing design improvements and changes to units in the field (for sustaining and service)

Familiarity with FDA quality requirements (ISO 13485, cGMP, QMS standards, USP class VI (biocompatibility testing))

Proficiency in SolidWorks CAD

Responsibilities:

Responsible for the design, development, prototyping, and volume manufacturing of complex injection molded assemblies and high-precision mechanical components & assemblies

Specifying injection molding tooling with state-of-the-art capabilities: Variotherm, vacuum assist, hot runners, etc

Design and development of manufacturing test fixtures as required

Identify & interface with key component vendors (suppliers of tubing, valves, etc., that may be integrated into our consumable design)

Interface with R&D systems & mechanical engineering teams to negotiate designs that meet product requirements & are feasible to manufacture economically