About the Job - The candidate needs to be a self-motivated individual skilled & has been part of product design & development phase of medical device product development & product lifecycle management. Good technical background in medical device (Class I & II) is desirable. Needs to design, develop & deliver product design, process development, verification & validation as per defined CTQ’s. Requires in-depth knowledge & experience in developing 3D CAD modelling, Prototyping, 2D Drafting, Geometric Dimensioning & Tolerance, Tolerance Stack Up Analysis & Value Engineering.
KEY RESPONSIBILITIES -
- Support the design & development of new medical products to meet customer requirements based on agreed CTQs
- Support development of design solutions, at component & final assembly level, to complex technical problems where analysis of data requires an in-depth evaluation of many factors. Design mechanical system & subsystems parts of medical product with CAD tools according to design rules & standards. Solutions require use of ingenuity & creativity.
- Create 2D manufacturing drawings & use of design change process to ensure the proposed changes are systematically & thoroughly analyzed.
- Support DFMEA (Design Failure Mode Effects Analysis) & risk analysis reviews on NPI - Resolve quality problems associated with design & act as a technical resource to other cross-functional engineers as needed.
- Design mechanical parts with consideration of DFM / DFA closely working with industrial Design team.
- Design & development of jigs & fixtures & Packaging for all products.
- Support mechanical design verification tests (e.g. shock & vibration, reliability tests etc) according to product specification & IEC standards
- Preparation of Work instructions & BOM for all products.
- Ability of Working Individual or in a Team Cross-Functional Teams
- Able to be occasionally flexible with working hours to support product launches / CUFT production.
- Knowledge of ECN / ECR Process, NC/CAPA process, Technical report writing etc.
TECHNICAL COMPETENCIES
- Medical product development experience & knowledge of ISO 13485 (preferably ISO 15004-1 & ISO 15004-2), FDA regulations & other regulatory standards preferred.
- Successful execution of Electro-mechanical systems /products /parts /processes involving product conceptualization to commercial release.
- Knowledge in medical grade material sciences & processing – Metals, Polymers, Plastics & other alternative materials & processes.
- Demonstrated aptitude of innovative mechanical design skills including but not limited to frequent use of 2D (AutoCAD) & 3D CAD (Solidworks) modelling & Model Based Definition, Simulation tools, GD&T, Tolerance stack-ups, drafting standards per ASME Y14.5 & prototype creation.
- Preferable Knowledge of Engineering tools like DFMA / DFMEA / DOE Fundamentals.
- Basic metrology skills to assist manufacturing with ensuring compliance with design specifications.
- Demonstrated experience in creation of typical failure analysis deliverables (Hazards Analysis, FMEAs, FTAs, etc.)
BEHAVIORAL COMPETENCIES
- Excellent attention to detail, ability to multi-task & Able to work with minimal supervision, both alone & in teams.
- Able to be occasionally flexible with working hours to support product launches / CUFT production.
