Senior Medical Device Mechanical Engineer

Intuvie Holdings LLC; Natick (MA); On-site; USD 104,042 - 108,000; Full time

Job summary

Intuvie Holdings LLC in Natick, MA is seeking Mechanical Engineers to develop and implement mechanical design for medical devices, applying advanced design methodologies, Python, and MATLAB.

The role requires a Master’s degree in Mechanical Engineering, Materials Science & Engineering, or Biomedical Engineering, plus hands-on 3D CAD modeling (AutoCAD, SolidWorks), GD&T, design verification/validation, and FDA 510(k) regulatory experience.

Qualifications

• Master’s degree in Mechanical Engineering, Materials Science & Engineering, or Biomedical Engineering.
• Experience with 3D CAD modeling and GD&T in medical device design.
• Knowledge of FDA 510(k) regulatory compliance and QMS processes.

Responsibilities

• Develop and implement mechanical engineering design for medical devices.
• Model and analyze complex assemblies using 3D CAD tools (AutoCAD, SolidWorks).
• Coordinate product releases in NP I process and perform design verification and validation.
• Ensure FDA 510(k) regulatory compliance of premarket submissions.
• Support manufacturing transfer and ramp-up via DFx concepts.

Skills

Advanced Mechanical Design

Python

MATLAB

AutoCAD

SolidWorks

3D CAD Modeling

GD&T

Tolerance Analysis

Manufacturing Integration

DFM

QMS

510(k) Regulatory

Education

Master’s Degree in Mechanical Engineering, Materials Science & Engineering, or Biomedical Engineering

Job description

Intuvie Holdings LLC in Natick, MA is seeking Mechanical Engineers to develop and implement mechanical design for medical devices, applying advanced design methodologies, Python, and MATLAB.

The role requires a Master’s degree in Mechanical Engineering, Materials Science & Engineering, or Biomedical Engineering, plus hands-on 3D CAD modeling (AutoCAD, SolidWorks), GD&T, design verification/validation, and FDA 510(k) regulatory experience.