Mechanical Engineer

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.