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