Mechanical Engineers

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Mechanical Engineers

Full Time Natick, MA, US

Salary Range: $104,042.00 To $108,000.00 Annually

Develop and implement mechanical engineering design for medical devices using knowledge of Advanced Mechanical Design, Python, MATLAB; Design, analyze, and interpret complex mechanical assemblies using AutoCAD, SolidWorks 3D/2D modeling, GD&T (Geometric dimensioning and tolerancing) practices; Coordinate product releases in compliance of NPI process, and complete design verification and validation; Evaluate material behavior under mechanical stress, environment exposure, and long-term usage conditions using mechanical test equipment, Formlab 3D Printer, IQ/OQ/PQ, d-FMEA, u-FMEA; Review and optimize product design and change controls in the manufacturing and engineering process using QMS, Manufacturing Integration; Ensure proper alignment between pump drive components and administration set using Tolerance Analysis and Mechanical Stack-up Evaluation; Create SOP and document technical design and process changes of medical devices; Coordinate manufacturing at client sites and implement DFM (Design for Manufacturing) concepts, to ensure successful product release; Provide technical solutions and guidance for the manufacturing transfer and ramp up process using Manufacturing system integration concepts; Diagnose and troubleshoot medical devices using principles of Electro-mechanical system; Ensure FDA 510 (K) regulatory compliance of premarket notification submissions for Class II medical devices.

Must have a Master’s Degree in Mechanical Engineering, Materials Science & Engineering, or Biomedical Engineering plus skills and knowledge in Advanced Mechanical Design, 3D CAD Modeling, Tolerance Analysis, Mechanical Stack-up Evaluation, SOP, QMS, Manufacturing Integration, 510 (K) Regulatory Compliance.