Mechanical Engineer

Zepto Life Technology, LLC. – Saint Paul, MN

The Mechanical Engineer role contributes to the design and development of single-use consumables for rapid in vitro diagnostic (IVD) tests. On the project team, this individual (alone or with a team) is responsible for the engineering portion of the consumable, including the design, solid modeling, materials selection, prototype molding, assembly, and testing. Collaboration with the broader R&D team, consisting of assay development scientists and instrument hardware/software engineers, is essential to delivering new products from concept to launch. The ideal applicant has experience in regulatory approval of IVD products, in plastic part design, molding and assembly processes.

TASKS AND RESPONSIBILITIES:

• 3D modeling using Solid Works or AutoCAD
• Convert user requirements into engineering specifications
• Understands assembly methods and customizes part design for simple, rapid assembly
• Designing for manufacturabilit
• Interfaces with cross-functional project team to ensure design requirements are met and product meets quality standards.
• Investigates and evaluates existing technology for application in a product.
• Develops new concepts from initial design to market release.
• Conducts feasibility studies of the design to determine ability to function as intended.
• Designs experiments, evaluates data, and makes recommendations based on data.
• Maintains detailed documentation throughout all phases of research and development and assist in transfer to manufacturing.
• Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines. Identifies and communicates with key contacts outside own area of expertise.
• Must be able to take responsibility for regulatory approval (FDA 510k, CE mark, etc.) of the product.
• Perform other duties & projects as assigned.

EDUCATIONAL BACKGROUND:

B.S. or above degree in Engineering.

EXPERIENCE:

Must Have:

• 2-5 years related experience.
• Experience in plastic part design and molding
• Experience with material selection and machining tolerance, 3D printing capabilities
• Ability to organize and structure bills of material and assembly drawings
• Basic understanding of pneumatic logic
• Basic understanding of electrical controls (PWM, stepper or servo motors, and temperature)
• Experience with manufacturing techniques and equipment for consumables assembly
• Demonstrated problem-solving and troubleshooting skills
• Strong verbal and written communication skills
• Organized and detail oriented
• Ability to work in a team environment

Nice to have:

• Successful contribution to regulatory approval of molecular diagnostic devices (FDA 510k, CE mark, etc.)
• Background in microfluidics

Interested candidates are requested to submit their resume and a cover letter. The cover letter must address how their background is relevant to the task of designing disposable IVD cartridge. Applications without a cover letter will not be considered.

Job Type: Full-time

Required experience:

• design and development: 2 years

Required education:

• Bachelor’s

Job Location:

• Saint Paul, MN