Mechanical Engineer

Katalyst CRO; Indianapolis (IN); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst CRO in Indianapolis is seeking a Technical Lead for mechanical design of electromechanical medical devices. You will own the mechanical architecture and guide the product from concept through production.

You will ensure regulatory compliance and collaborate with cross-functional teams to enable manufacturing transfer and risk management across the full lifecycle.

Qualifications

• Bachelor's or Master's degree in Mechanical Engineering with 8+ years in medical device NPD.
• Proficiency in CAD tools (SolidWorks or Creo) and GD&T.
• Experience with regulated manufacturing standards and risk management.

Responsibilities

• Act as technical lead for mechanical design of electromechanical medical devices.
• Own mechanical architecture and oversee full product lifecycle from concept to production.
• Ensure regulatory compliance and collaborate with cross-functional teams for manufacturing transfer.

Skills

Mechanical Design

SolidWorks

Creo

GD&T

DFM/DFA

FEA

ISO 13485

FDA 21 CFR 820

ISO 14971

Risk Management

Tolerance Stackup

Electromechanical Integration

Design History File

Medical Device NPD

Thermal Analysis

EMI/EMC Design

Education

Bachelor's degree in Mechanical Engineering

Master's degree in Mechanical Engineering

Tools

SolidWorks

Creo

Job description

Act as the technical lead for mechanical design of electromechanical medical devices, overseeing the full product lifecycle from concept to production. Responsibilities include owning mechanical architecture, ensuring regulatory compliance, and collaborating with cross-functional teams for manufacturing transfer.

Requirements: Requires a Bachelor's or Master's degree in Mechanical Engineering and over 8 years of experience in medical device new product development. Candidates must demonstrate proficiency in CAD tools like SolidWorks or Creo and expertise in GD&T and regulated manufacturing standards.

Key Skills: Mechanical Design, SolidWorks, Creo, GD&T, DFM/DFA, FEA, ISO 13485, FDA 21 CFR 820, ISO 14971, Risk Management, Tolerance Stackup, Electromechanical Integration, Design History File, Medical Device NPD, Thermal Analysis, EMI/EMC Design