Design & development of mechanical components & systems in the medical device domain, working on multiple projects simultaneously
Job Summary
Design & development of mechanical components & systems in the medical device domain, working on multiple projects simultaneously.
Creation or remediation of Design History Files, Device Master Records, and other related technical documents including drawings, labelling, and instructions for use.
Execution of NC CAPA implement design controls & risk controls and liaison with lab team to carry out verification and validation activities.
Matching Summary
Design & development of mechanical components & systems in the medical device domain, working on multiple projects simultaneously.
Skills & Requirements
Must-have
Design History Files
Device Master Records
engineering change process
plastic films and film blown extrusion
soft goods and plastic parts design
medical device standards and regulations
Nice-to-have
Analytical problem solvers
Dedicated achievers
Curious learners
Goal-oriented developers
User-focused creators
Collaborative partners
Motivated product launchers
Key Requirements
Master/Bachelor’s in Engineering, Mechanical Engineering
3+ years of work experience
Strong technical ability in creating engineering drawings and models
Applying GD&T and CAE tools
Interpreting design, analyzing, and doing DFM, DFI, materials and manufacturing
Adept at applying knowledge of materials and manufacturing processes
Ability to communicate moderate complexity plans and technical information
Good working knowledge of CAD applications (Creo/SolidWorks/UniGraphics)
Experience with analysis tools, specifically tolerance analysis and FEA using ANSYS software
Competency in statistics, process capability, design of experiments, including statistical applications such as Minitab
Experience in working with regulated industries like Medical devices, Aerospace, Automotive etc.