The role involves developing innovative medical devices that improve patient care and advance healthcare technology
Job Summary
The role involves developing innovative medical devices that improve patient care and advance healthcare technology.
Candidates will collaborate with cross-functional teams including engineering, sales, and regulatory affairs to ensure successful project outcomes.
The position requires maintaining detailed documentation of design control and risk management activities in accordance with quality management systems.
Matching Summary
The role involves developing innovative medical devices that improve patient care and advance healthcare technology.
Skills & Requirements
Must-have
Design and prototype medical devices
Execute testing protocols for validation
Maintain detailed design control documentation
Ensure regulatory compliance with FDA standards
Proficiency in 2D and 3D CAD modeling
Nice-to-have
Knowledge of statistical techniques like DoE
Experience with Six Sigma methodologies
Familiarity with ISO 13485 standards
Collaboration with cross-functional teams
Commitment to quality and safety culture
Key Requirements
Minimum Level 8 degree in Biomedical or Mechanical Engineering
Minimum 2 years industry experience in R&D
Experience with medical device development processes