Medical Surgical Fiber Product Manager

Key Responsibilities

• Identifying opportunities for innovation in design, manufacturing, and testing
• Managing the internal fiber component portfolio to ensure lifecycle alignment, standardization, reuse, and cost efficiency
• Driving internal innovation to enhance performance, manufacturability, and cost-effectiveness of fiber products
• Serving as the primary technical point of contact for external vendors and customers, ensuring clear and effective communication
• Managing budgets, resources, and timelines to ensure timely and cost-effective project delivery
• Meting performance, quality, and cost benchmarks, with a focus on shortening development cycles through process improvements

Requirements

• Education and Experience: Bachelor's degree in an Engineering discipline, Master's degree preferred; Minimum of 10 years of experience in research and development of fiber medical products; 5+ years of experience managing engineering teams within organizations operating under ISO 13485 and FDA protocols, covering all phases from design input through transfer to production
• Project Management: Advanced project management skills, including reporting and presentation capabilities
• Communication: Excellent written and verbal communication skills
• Experience: Hands-on experience with optical, electrical, mechanical, and electronic lab experimentation involving fiber medical products; Proven track record of delivering complex, cross-functional projects on time and within budget; Ability to manage multiple projects in a fast-paced development environment
• Knowledge: Demonstrated experience working within a controlled product development process; Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366, is preferred