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USD
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210000
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true
Staff Mechanical Engineer
2025-09-12
2025-11-01
Employment Type:
Direct
Category: Mechanical Engineer
Job Number: 10376
Pay Rate: $150K - $210K
Job Description
Qualifications:
Responsibilities:
- BS/MS Mechanical Engineering, 12+ years of experience in biotech automation or semiconductor process equipment industries
- SWx, GD&T, Python
- ISO, FDA, cGMP, QMS (regulatory requirements and documentation)
- Broad experience in complex mechanical systems for material handling (mechanisms), temperature control, fluid handling and dispensing, optical & optomechanical systems
- Experience with laboratory automation is preferred
- Strong familiarity with manufacturing processes such as precision machining, injection molding
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