Senior Mechanical Engineer - Medical Devices NPD

Katalyst CRO; Cincinnati (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a lead mechanical design engineer to steer the design and development of medical devices. You will concentrate on 3D stack-up and tolerance analysis while guiding projects from concept through release.

The role requires deep experience in mechanical design, NPD processes, and regulatory awareness (ISO 13485, FDA QSR). You will collaborate across functions to ensure design for manufacturability.

Qualifications

• 5+ years of mechanical design experience, preferably in the medical device industry.
• Knowledge of regulated environments such as ISO 13485 and FDA QSR; familiarity with DFM and DFA.

Responsibilities

• Lead mechanical design and development activities for medical device programs with a focus on 3D stack-up and tolerance analysis.
• Execute the New Product Development lifecycle from concept to release while managing engineering change processes.

Skills

3D Stack-up Analysis

Tolerance Analysis

New Product Development

CAD

Creo

SolidWorks

NX

Engineering Change Management

ECO/ECR

ISO 13485

FDA QSR

DFM

DFA

Mechanical Design

Medical Device Development

Tools

Creo

SolidWorks

NX

Job description

Katalyst CRO is seeking a lead mechanical design engineer to steer the design and development of medical devices. You will concentrate on 3D stack-up and tolerance analysis while guiding projects from concept through release.

The role requires deep experience in mechanical design, NPD processes, and regulatory awareness (ISO 13485, FDA QSR). You will collaborate across functions to ensure design for manufacturability.