Responsibilities
- Responsible for the design, development, and prototyping of mechanical components & complex biotech instruments and mechanical sub-systems
- Interface with systems & mechanical engineering teams to negotiate designs that meet product requirements & are feasible to manufacture economically
- Work closely with Electrical, Controls, & Systems engineers on complex electromechanical designs
- Ability to be a technical lead on complex projects that encompass electrical, mechanical, controls disciplines, and work for our internal customers
- Conduct design reviews and present fresh ideas, new technologies and creative solutions to design problems
- Define subsystem architecture
- Show proof of concept through rapid prototyping; your skills will be used to build and test your own assemblies
- Ability to extract design requirements from a broad spectrum of user needs
- Identify potential design risks and provide a path to rapid derisk/pivot
- Design and develop automated test fixtures to validate reliability and robustness of novel components
- 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
Requirements
- BS or MS in Mechanical Engineering, Mechatronics Engineering, or equivalent experience
- 5-10 years of extensive, hands-on experience in the semiconductor, biotech automation, or similar industries
- Prior experience with Injection-Molded fluidic components a plus
- 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
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