The Medical Surgical Fiber Product Portfolio Manager is responsible for leading R&D efforts for all medical fiber products, with a strong emphasis on innovation, reliability, and alignment with company strategy. This role oversees all phases of the product design lifecycle—from defining design inputs and outputs, through verification and validation, to transfer to manufacturing.
Requirements
- 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.
- Hands-on experience with optical, electrical, mechanical, and electronic lab experimentation involving fiber medical products.
- 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.
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.
- Meeting performance, quality, and cost benchmarks, with a focus on shortening development cycles through process improvements.
- Hands-on experience with optical, electrical, mechanical, and electronic lab experimentation involving fiber medical products.
Other
- Bachelor's degree in an Engineering discipline, Master's degree preferred.
- Advanced project management skills, including reporting and presentation capabilities.
- Excellent written and verbal communication skills.
- 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.
