Lead Mechanical Engineer - Medical Devices Design & Regs

Katalyst CRO; Tampa (FL); On-site; USD 120,000 - 190,000; Full time

Job summary

Katalyst CRO in Tampa, FL seeks a technical lead for mechanical design in electromechanical medical device programs. You will own mechanical architecture, drive regulatory compliance, and shepherd products from concept through production, coordinating cross‑functional teams for manufacturing transfer.

This role demands deep GD&T expertise, proficiency in SolidWorks or Creo, and a track record in regulated medical device development.

Qualifications

• Experience leading mechanical design in electromechanical medical device programs.
• Deep knowledge of GD&T and tolerance analysis.
• Understanding of regulatory requirements for medical devices (FDA/ISO 13485).

Responsibilities

• Own mechanical architecture for electromechanical devices.
• Drive regulatory compliance across development stages.
• shepherd products from concept through production and manufacturing transfer.
• Coordinate cross-functional teams to enable manufacturing transfer and scaling.

Skills

Mechanical design

Regulatory knowledge

GD&T

Tools

SolidWorks

Creo

Job description

Katalyst CRO in Tampa, FL seeks a technical lead for mechanical design in electromechanical medical device programs. You will own mechanical architecture, drive regulatory compliance, and shepherd products from concept through production, coordinating cross‑functional teams for manufacturing transfer.

This role demands deep GD&T expertise, proficiency in SolidWorks or Creo, and a track record in regulated medical device development.