Responsibilities
- Responsible for the design, development, and prototyping of mechanical components and consumables used in mechanical sub-systems & complex biotech instruments
- Design and development of automated test fixtures to validate the 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
- Define subsystem architecture
- Show proof of concept through rapid prototyping
- Ability to extract design requirements from a broad spectrum of user needs
- Identify potential design risks and provide a path to derisk/pivot rapidly
- Work closely with the scientific team through the creation of verification /validation protocols (IQ, OQ, PQ) and successful execution, data generation, report and documentation
- Create comprehensive work instructions and manufacturing SOPs as needed for finished designs
- BS or MS in Mechanical Engineering, Mechatronics Engineering, or equivalent experience
- 10+ years of extensive, hands-on experience in biotech automation, semiconductor, or similar industries
- Excellent verbal, written, presentation, and interpersonal skills
- Strong analytical and problem-solving skills
- Prior experience with FDA regulations and ISO, cGMP, and QMS standards is a plus
- Knowledge and/or hands-on experience with machine shop tools a plus
- knowledge of GD&T, as well as strong proficiency with SolidWorks
- Creative, self-motivated, and flexible to work in a small company environment and assume a wide variety of tasks
- Work history with several successful iterations of highly automated instrument design and development (biotech industry experience preferred)
- Desire to be part of a rapidly evolving organization with compelling technology and take products and processes to the next level
- Experience with Python, or high-level scripting software languages, a plus
- Self-awareness, integrity, authenticity, and a growth mindset
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