Biocon - Principal Engineer - Research & Design - Medical Devices Domain

Principal Engineer - Research & Design - Medical Devices

- PhD/ ME/Msc/BE (Mechanical /Industrial/ Production/ Bio-Medical/plastics Tech) with 12-15+ Yrs Exp.

- Experience in New Product Introduction, Product Design, R&D and development of Disposable and re-usable Drug delivery systems

- Experience With User studies, pre-clinical and clinical studies

- Experience With Concept design, evaluation, concept to product translation of requirements, Design Specification generation

- Experience With industrial design, prototyping,

- Experience with complex plastic injection molding for development of components, sub-assemblies, and assemblies.

- Development of Design rational, design analysis and evaluation

- Hands on experience with CAD,CAM, CAE and mold flow analysis

- GD&T, Tolerance Stack-up analysis, Plastic injection molding process design, evaluation

- Experience with selection of Material of construction, manufacturing process

- Experience with Systems engineering approach desired

- Vendor assessments, evaluation and audit support

- Experience with leading design programs and cross functional team co-ordination with major stakeholder like marketing, clinical R&D, RA and QA

- Design experience with Pen Injectors, Auto-Injectors, On-body injectors, Infusion Pumps, Infusion devices is desirable

- Exposure to US FDA Part 820, Design Controls, ISO 13485, ISO 14971, IEC 60601, CE marking for Medical Devices, EU MDD, EMA desired.

- Audit management support, CAPA investigations, support to collateral functions like Drug R&D, Packaging and Labeling desired

- Experience with Design calculations, Hypothesis testing, DoE, QFD important

- Knowledge of DFMA, Design for Cost, Reliability, Serviceability

- Knowledge of manufacturing processes like machining, sheet metal fabrication, welding over and above plastic molding

- Strong technical problem solving aptitude.

- Proven performance with contributions to IP creation, Patent filing, Idea generation important.

- Knowledge of commercial strategies and plans and ability to translate business requirements into product level functions

- Good team management and interpersonal skills

- Ability to communicate effectively and fluently with all stakeholders