Senior Mechanical Engineer (I,II,III)

Responsibilities

• Responsible for the design, development, and prototyping of mechanical components & complex biotech instruments and mechanical sub-systems
• Design and development of automated test fixtures to validate reliability and robustness of novel components
• Interface with systems & mechanical engineering teams to negotiate designs that meet product requirements & are feasible to manufacture economically
• Conduct design reviews and present fresh ideas, new technologies and creative solutions to design problems
• Show proof of concept through rapid prototyping
• Work closely with the scientific team through the creation of verification /validation protocols (IQ,OQ,PQ) as well as successful execution, data generation, report and documentation
• Create comprehensive work instructions and manufacturing SOP’s as needed for finished designs

Requirements

• BS or MS in Mechanical Engineering, Mechatronics Engineering, or equivalent experience
• 5-11 years of extensive, hands-on experience in the semiconductor, biotech automation, or similar industries
• Excellent verbal, written, presentation and interpersonal skills
• Strong analytical and problem-solving skills
• Prior experience with FDA regulations and ISO, cGMP, QMS standards is a plus
• Knowledge and/or hands-on experience with machine shop tools is a plus
• Knowledge of GD&T as well as strong proficiency with SolidWorks
• Creative, self-motivated, flexible to work in a start up environment
• Work history with several successful iterations of highly automated instrument design and development (non-biotech industry experience is OK)
• Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level
• Some experience with python, or high level scripting software languages, a plus
• Self-awareness, integrity, authenticity, and a growth mindset