Job Description

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 handheld device.

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Summary*
Zepto is seeking a Mechanical/Microfluidic Consumable Engineer to design and develop microfluidics consumables for immunoassay and molecular assay for rapid in-vitro (IVD) testing. The Mechanical Engineer is responsible for definition, design, molding, assembly, and testing processes for IVD applications. The Mechanical/Microfluidic Consumable Engineer reports to the Senior Mechanical Engineer Lead, but will work with a team consisting of Assay Development Scientists and Hardware/Software Engineers. The Mechanical/Microfluidic Engineer will not have supervisory responsibilities.

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Essential Duties*

• Define and design microfluidics consumables for immunoassay and molecular assays for IVD application.
• Prototype microfluidic consumable modules to prove fluid control, valving, mixing, and other fluid management functions.
• Design and develop integrated microfluidic consumables, which may include sample preparation, amplification, reagent mixing, target amplification and detection.
• Select plastic materials for microfluidic device fabrication and assembly. Develop consumables using various methods, including lamination, machining, 3D printing, laser cutting and injection molding.
• Provide solutions for consumable assembly to support large scale testing and production.
• Design plastic consumables for injection molding, including soft and hard tool, and generate engineering specifications and drawings.
• Work with manufacturing vendors on design for manufacturing (DFM).
• Perform risk analysis and propose mitigation for consumables design.
• Carry out root-cause analysis for failures.
• Develop, document and execute test plans and analyze resulting data.
• Design, develop and fabricate testing fixtures as needed.
• Interface with cross-functional project team to ensure design requirements are met and product meets quality standards.
• Coordinate activities with supplies to ensure the delivery of supplies or services needed to meet schedules timelines.
• Maintain compliance to QMS, FDA Design Control and other IVD regulatory standards.

Required Education and Experience

• Bachelors or Masters in Mechatronics, Mechanical, Electrical Engineering, or similar. Open to new grads!
• Profound understanding of microfluidics and microscale fluidics.
• 1+ years experience in SolidWorks and drawing standards (including GD & T).
• 1+ years experience in consumable design for medical device, life science, or similar.
• 1+ years experience in plastic part design and molding
• Experience with material selection and machining tolerance, 3D printing capabilities
• Experience with manufacturing techniques and equipment for consumables assembly

Preferred Education and Experience

• Demonstrated ability to design, develop and execute testing
• Plastic injection, joining, fabrication, and assembly, as well as tolerance analysis

Competencies

• Ability to work together in a multi-disciplinary 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

• This job operates in a research and development biosafety level 2 lab. Strict 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.

Visa Support:

• For qualified applicants, the company can support OPT, CPT and H1B.

Job Type

• Full-time, Monday-Friday, Onsite. Some traveling may be required.
• Benefit eligible (PTO, Sick Time, Health Insurance (Medical, Dental, and Vision), HSA, and Life Insurance)

E-Verify
Zepto Life Technology participates in the U.S. Department of Homeland Security E-Verify program in all facilities located in the United States and certain U.S. territories. The E-Verify program is an Internet-based employment eligibility verification system operated by the U.S. Citizenship and Immigration Services. Learn more about the E-Verify program.

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**This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change or new ones may be assigned at any time with or without notice.**_

Job Type: Full-time

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