The role involves designing, prototyping, and testing innovative medical devices to improve patient care while ensuring compliance with FDA and ISO 13485 standards
Job Summary
The role involves designing, prototyping, and testing innovative medical devices to improve patient care while ensuring compliance with FDA and ISO 13485 standards.
Candidates will collaborate with cross-functional teams including engineering, sales, quality assurance, and regulatory affairs to deliver successful project outcomes.
The position requires maintaining detailed documentation of design controls and risk management activities within a culture that values innovation and integrity.
Matching Summary
The role involves designing, prototyping, and testing innovative medical devices to improve patient care while ensuring compliance with FDA and ISO 13485 standards.
Skills & Requirements
Must-have
Biomedical or Mechanical Engineering degree
2D and 3D CAD modeling proficiency
Medical device development experience
FDA and ISO 13485 regulatory knowledge
Design verification and validation skills
Nice-to-have
Statistical techniques like DoE and Six Sigma
Experience with Minitab software
Cross-functional team collaboration
Process improvement initiatives
Supplier and vendor engagement
Key Requirements
Minimum Level 8 degree in Biomedical or Mechanical Engineering