Mechanical Engineers

Mechanical Engineer For Medical Devices

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, Solid Works 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.

Job location:

Natick, MA. $104,042~$108k per year. Submit résumé referencing job code BIY
002 to HR, Zyno Medical, LLC, 177 Pine Street, Natick, MA 01760.