A medical device company operating in the field of Ophthalmology is seeking to hire an engineer to join our V&V and R&D activities.
Responsible for all aspects of medical device product development from concept to manufacturing
In charge of all elements of design control and documentation:
Risk management, planning, design input/output, verification & validation, change control, specifications, SOPs, test protocols, records and reports (STD, test protocols, STR).
Create and maintain a Design History File (DHF) and Device Master Record (DMR).
Leading the V&V process plan , test protocols, tests execution, results analysis and test report
Responsibility for implementing V&V procedures in accordance with the work instructions.
Design and implement experiments for various projects.
Lead verification and validation efforts for new products and components.
Document experiments / testing methodically including result summary , analysis and interpretation.
Writing system documentation – Take part in preparations of technical quality reporting documentation.
Participate in defining and executing R&D programs.
Assist the production activities as needed.
Logistic support to marketing activities.
Reports to VP of R&D
Requirements:
Apply “systems” thinking and knowledge of systems (SW+HW).
Quality assessments of product and development practices, compliance with all FDA requirements and IEC 60601 standards, EMC and ESD. Support ISO 13485 certificate.
Minimum of a Bachelor of Science Degree in Electrical Engineering with at least 10 years’ experience with all aspects of medical device product development, design control and verification & validation for medical devices, from planning to execution.
Excellent verbal and written communication
English at native level
