Zepto Life Technology seeks to innovate and develop a highly sensitive and multiplexed immunoassay and molecular diagnostics technology platform that can quickly diagnose diseases and determine medical interventions using a Point of Care (POC) device. We are building a multidisciplinary team with talents from biology, material science, engineering, and clinicians to integrate the leading technologies into a clinical product.
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Summary*
Zepto is seeking a Senior Mechanical Engineer to design and develop the mechanical system in an integrated molecular diagnostic instrument. The mechanical system will interface with a consumable cartridge and activate the functional components on the cartridge to complete a test. It consists of multiple linear/ rotary motions, and temperature control and they are in a compact size. The Mechanical Engineer is responsible for conceiving, designing, building, and testing processes for the functions of the mechanical system. The Mechanical Engineer reports to the system development Lead but will work with a team consisting of a consumable design team, Assay scientists, electrical engineers, and Hardware/Software Engineers.
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Essential Duties*
- Review existing designs and evaluate them and give feedback to the team.
- Concept the cartridge and instrument interface, review the ideas with the team, and make decisions on the concept with teams.
- Design the mechanical structure and mechanisms that are needed for all the cartridge activation functions. Evaluate the design and carry out a risk analysis with the team to mitigate the risks.
- Give feedback on the consumable design on the interfacing features and help consumable teams to understand the instrument constraints.
- Work with consumable teams together to finalize the system design.
- Perform tolerance analysis to make sure the functions can be achieved reliably and repeatedly.
- Communicate with external vendors for parts fabrication and assembly.
- Make test plans and generate test specifications for the instrument.
- Prototype modular mechanical functions and integrated systems.
- Build and test the system with the team.
- Make improvements and optimization for the instrument based on test results.
- Carry out root cause analysis for failures and the understanding of the fundamental physics causing the failure.
- Manage the system design requirements and document them.
- Interface with the cross-functional project team to ensure design requirements are met and the product meets quality standards
- Coordinate activities with supplies to ensure the delivery of supplies or services needed to meet scheduled timelines.
- Maintain compliance to QMS, FDA Design Control, and other IVD regulatory standards.
Required Education and Experience
- BS or MS in Mechanical Engineering, Material Engineering, Physics, Biomedical Engineering or similar with 5 or more years of experience or Ph.D. with 3 years of experience.
- Proven evidence of compact mechanical design experience.
- Proven evidence of mechanism design experience.
- Three or more years experience in SolidWorks and drawing standards (including GD & T).
- Experience in instrumentation.
- Experience in temperature control.
Preferred Education and Experience
- Demonstrated ability to design and develop compact machines using different mechanisms with multiple motions.
- Demonstrated ability to design and develop miniaturized machines with multiple motions.
Competencies
- Ability to work together in a multidisciplinary team
- Self-motivation and ownership of responsibilities
- Ease with technology
- Strong technical writing skills
- Ability to organize and structure bills of material and assembly drawings
Work Environment
- The device under development is a regulated product. Adherence to corporate policies and regulations in these areas is required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Job Type:
- Full time, Monday-Friday 9:00 am - 5:30 pm (half-hour unpaid lunch), onsite in the lab. Benefit eligible.
Job Type: Full-time