Mechanical Engineer

Reprotech, LLC•Indianapolis, IN

About The Position

TMRW, part of the Reprotech family of companies, develops technology and systems that support the safe identification, management, storage, and handling of reproductive cells. Its mission is centered on reducing risk and improving quality within fertility care. The Mechanical Engineer is responsible for designing and updating hardware components and developing new labware products, on-market products, and supporting manufacturing activities for cryogenic storage and medical device products. The role works across multiple projects and collaborates with cross-functional teams to develop, test, document, and validate mechanical designs.

Requirements

Bachelor’s degree in mechanical engineering or a related field.
Five years of experience in mechanical design principles, materials, and manufacturing processes.
Proficiency in SolidWorks CAD software and simulation tools.
Ability to create and maintain detailed engineering documentation, including CAD models, drawings, specifications, and test plans.
Knowledge of dFMEA/pFMEA, DFX, tolerance stack-up analysis, and GD&T.
Demonstrated technical writing ability, specifically for controlled process documentation in a regulated industry.
Exceptional technical presentation and communication skills.
Ability to manage multiple tasks and projects simultaneously.
Basic knowledge of metals and materials, their application in mechanical parts fabrication, rapid prototyping, and testing.

Nice To Haves

Experience with medical device regulations, including FDA, ISO 13485, ISO 14971, and IEC 60601.
Experience with manufacturing processes including injection molding, vacuum forming, thermoforming, 3D printing, and CNC machining.

Responsibilities

Design and develop mechanical solutions that improve performance, safety, reliability, throughput, and cost-effectiveness.
Independently lead and manage the design change process.
Manage multiple projects through proper project planning with minimal guidance.
Conduct root cause analysis and implement corrective actions.
Collaborate with cross-functional teams to resolve manufacturing and field issues, conduct feasibility studies and risk assessments, perform design reviews, and validate designs through analysis and testing.
Use computer-aided design (CAD) to create detailed prototypes and design iterations.
Generate design control documents, including product requirements, drawings, label specifications, manufacturing specifications, and risk documents such as Design and Process FMEA.
Evaluate proofs and prototypes and execute First Article Inspections (FAIs) to validate design integrity and compliance.
Conduct product testing and design verification testing to ensure product performance meets established standards.
Participate in cross-functional projects and initiatives.
Perform other duties as assigned.