At Alcon, the business problem is to enhance sight and help people see brilliantly by innovating fearlessly and delivering new products and services to revolutionize the eye care industry and advance optimal patient outcomes.
Requirements
- Medical device product development (electrical, mechanical, optical, software)
- Design control for medical devices development (21 CFR 820.30, ISO 13485, MDD/MDR)
- Risk Management for medical devices (ISO 14971)
- SW development for medical devices (IEC 62304), including SiMD and SaMD
- Medical electrical equipment basic safety & essential performance IEC 60601 series
- Usability Engineering for medical devices (IEC 62366-1)
- Product Security for medical devices
Responsibilities
- Contribute to research-driven product development, focusing on design optimization, material characterization, and advanced computational modeling
- Evaluate product performance through in-depth analysis, using empirical and theoretical data to refine design specifications
- Support regulatory submissions, data validation efforts, and scientific research to ensure product safety and efficacy
- Engage in cross-disciplinary collaboration to integrate novel research findings into product development strategies
- Responsible for developing Design History Files (DHFs) and Risk Management Files (RMFs) that support effective and efficient global registrations and launches of quality products
- Acts as Subject Matter Expert (SME) on design control and risk management processes, including FDA 21 CFR 820.30, FDA guidance, European MDD and MDR, MDCGs, ISO 13485, ISO 14971, IEC 62304, IEC 60601 and Alcon Quality System
- Plans and owns, or drives execution, of quality and value-add design control and risk management deliverables in collaboration with project core teams and functional stakeholders
Other
- Bachelor’s Degree or Equivalent years of directly related experience
- The ability to fluently read, write, understand, and communicate in English
- 5 Years of Relevant Experience
- Travel Requirements: 0-5%
- Relocation assistance: Yes
