Lead Mechanical Engineer - Medical Devices

Katalyst CRO; Tampa (FL); On-site; USD 110,000 - 160,000; 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

• Bachelor's or Master's degree in Mechanical Engineering.
• 8+ years of experience in medical device new product development.
• Proficiency in CAD tools such as SolidWorks or Creo.
• Deep expertise in GD&T and regulated manufacturing standards.

Responsibilities

• Act as the technical lead for mechanical design in electromechanical medical device programs.
• Oversee full lifecycle from concept to production, own mechanical architecture, ensure regulatory compliance, and coordinate manufacturing transfer.

Skills

Mechanical Design

Electromechanical Integration

SolidWorks

Creo

GD&T

DFM/DFA

FEA

ISO 13485

FDA 21 CFR 820

ISO 14971

Risk Management

Tolerance Stackup

Design History File

Medical Device Development

Prototyping

BOM Management

Education

Bachelor's or Master's degree in Mechanical Engineering

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.