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.
Job location: Natick, MA. $104,042~$108k per year. Submit résumé referencing job code BIY002 to HR, Zyno Medical, LLC, 177 Pine Street, Natick, MA 01760.
