Mechanical and Electrical Technician

Job description

**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.