Mechanical Engineers

Intuvie•Natick, MA

2d•$104,042 - $108,000•Onsite

About The Position

Zyno Medical, LLC is seeking Mechanical Engineers to develop and implement mechanical engineering designs for medical devices. This role involves utilizing expertise in Advanced Mechanical Design, Python, and MATLAB for design and analysis. The engineer will be responsible for designing, analyzing, and interpreting complex mechanical assemblies using AutoCAD and SolidWorks, adhering to GD&T practices. Key responsibilities include coordinating product releases in compliance with the NPI process, completing design verification and validation, and evaluating material behavior under various conditions using specialized equipment and methodologies like Formlab 3D Printer, IQ/OQ/PQ, d-FMEA, and u-FMEA. The role also requires reviewing and optimizing product designs and change controls within the QMS and Manufacturing Integration framework, ensuring proper alignment of pump drive components and administration sets through Tolerance Analysis and Mechanical Stack-up Evaluation. Additionally, the engineer will create SOPs, document technical changes, coordinate manufacturing at client sites with DFM concepts, provide technical solutions for manufacturing transfer and ramp-up using Manufacturing system integration, diagnose and troubleshoot electro-mechanical systems, and ensure FDA 510(K) regulatory compliance for Class II medical devices.

Requirements

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

Nice To Haves

Python
MATLAB
AutoCAD
SolidWorks 3D/2D modeling
GD&T (Geometric dimensioning and tolerancing) practices
mechanical test equipment
Formlab 3D Printer
IQ/OQ/PQ
d-FMEA
u-FMEA
DFM (Design for Manufacturing) concepts
Electro-mechanical system principles

Responsibilities

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