The role involves leading the design and development of medical devices from concept to launch while ensuring strict compliance with FDA QSR, GMP, and ISO 13485 regulations
Job Summary
The role involves leading the design and development of medical devices from concept to launch while ensuring strict compliance with FDA QSR, GMP, and ISO 13485 regulations.
Candidates will collaborate with multifunctional teams to resolve technical challenges using Design for Manufacturing and Design for Assembly methodologies.
Responsibilities include maintaining expertise through publications and patents while chairing technical design reviews and managing design history file documentation.
Matching Summary
The role involves leading the design and development of medical devices from concept to launch while ensuring strict compliance with FDA QSR, GMP, and ISO 13485 regulations.
Skills & Requirements
Must-have
Design control process management
DHF documentation authoring
Infusion Care product development
Design for Manufacturing methodologies
Statistical analysis and DOE
CAD/CAM software proficiency
Nice-to-have
Cross-functional team leadership
User-centric design focus
Rapid simulation techniques
Continuous improvement mindset
Stakeholder expectation management
Key Requirements
Bachelor's degree in Science or Engineering
Experience in Medical Device regulated industry
Knowledge of injection molding and plastics technologies