Staff Mechanical Engineer
Posted on 2/22/2023
INACTIVE
Locations
San Bruno, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Python
SolidWorks
Requirements
- BS or MS in Mechanical Engineering, Mechatronics Engineering, or equivalent experience
- 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
- 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, 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 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
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
- 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 rapidly de-risk/pivot
- 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
Desired Qualifications
- Prior experience with FDA regulations and ISO, cGMP, QMS standards is a plus