Mechanical Engineer

ReproTech; Indianapolis (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

TMRW, part of the Reprotech family, seeks a Mechanical Design Engineer to design and update hardware components for cryogenic storage and medical devices. You will lead design changes, develop labware products, and support manufacturing activities across R&D and production teams.

The role requires a BS in mechanical engineering with 5+ years in mechanical design, strong CAD skills (SolidWorks), and experience with regulated medical device development.

Qualifications

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Responsibilities

• Design and develop mechanical solutions to improve performance, safety, reliability, throughput and cost-effectiveness.
• Lead design changes independently and manage the design change process.
• Handle multiple projects with proper planning and minimal guidance.
• Conduct root cause analysis and implement corrective actions.
• Collaborate with cross-functional teams to resolve manufacturing and field issues, conduct feasibility studies, risk assessments, and design reviews; validate designs through analysis and testing.
• Employ CAD to create detailed prototypes and design iterations.
• Generate design control documents including requirements, drawings, labels, manufacturing specs, and risk documents such as DFMEA and PFMEA.
• Evaluate proofs and prototypes and perform FAIs to validate design integrity and compliance.
• Conduct product testing and design verification testing to ensure performance meets standards.
• Participate in cross-functional projects and initiatives.
• Other duties as assigned.

Skills

CAD design

Technical writing

Cross-functional collaboration

Communication

Project management

Education

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks CAD

Simulation tools

dFMEA/pFMEA

GD&T

Job description

Description

TMRW, part of the Reprotech family of companies, develops technology and systems that support the safe identification, management, storage, and handling of reproductive cells. TMRW's mission is centered on reducing risk and improving quality within fertility care.

Position Summary

This role is responsible for the design and/or updating of hardware components and the development of new labware products, on-market products and supporting manufacturing activities for our cryogenic storage and medical device products.

Requirements

Key Duties & Responsibilities

• Design and develop innovative mechanical solutions to improve performance, safety, reliability, throughput and cost-effectiveness.
• Act as a change lead, managing the Design change process independently.
• Handle multiple projects with proper project planning and minimal guidance.
• Conduct root cause analysis and implement corrective actions.
• Collaborate with cross-functional teams to resolve manufacturing and field issues, conduct feasibility studies, risk assessments, and design reviews and validate designs through analysis and testing.
• Employ 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, executing First Article Inspections (FAIs) to validate design integrity and compliance.
• Conduct product testing and design verification testing to ensure product performance meets established standards.
• Participates in cross functional projects and initiatives.
• Other duties as assigned.

Education/Experience

• Bachelor’s degree in mechanical engineering or a related field with 5 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 ability in technical writing, 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, its application knowledge on mechanical parts fabrication, Rapid prototyping and testing.
• Experience with medical device regulations (FDA, ISO 13485, ISO 14971, IEC 60601) is a plus.
• Experience with manufacturing processes including injection molding, vacuum forming, thermoforming, 3D Printing, CNC Machining is also a plus.

Reasonable accommodation may be given to qualified individuals with disabilities to perform the essential functions of the job.