Key Responsibilities
- Prototyping & Testing: Fabricate, assemble, and test prototype orthopedic instruments and implants to validate design requirements.
- Lab Management: Maintain laboratory equipment and manage calibration schedules.
- Technical Documentation: Create and update technical documentation, including test reports, CAD models (if applicable), and design history files.
- Evaluation: Evaluate prototype samples for product stability, safety, and functional performance.
- Supplier Interaction: Work with vendors for customized components and material selection.
- Design Changes: Implement design changes to existing orthopedic products based on customer feedback, quality trends, or cost-saving initiatives.
- Root Cause Analysis: Perform investigations and testing to identify root causes of field failures or manufacturing issues.
- Validation: Carry out verification and validation testing for design changes (V&V).
- Risk Management: Assist in updating Risk Management Files (FMEA) for existing products.
Cross-functional Collaboration
- Collaboration: Collaborate with Orthopedic Specialists, Quality Assurance, Regulatory Affairs, and Manufacturing teams to support the product life cycle.
- Compliance: Ensure all technical work complies with FDA, ISO 13485, and other regulatory standards.
