I have been engaged by an innovative medical device organization developing next-generation healthcare technologies designed to improve patient outcomes. My client is advancing precision medical solutions through cutting-edge engineering, laser-based technology, and a strong commitment to quality and continuous innovation. Their collaborative, high-performance environment empowers teams to push boundaries and deliver meaningful impact in patient care.
This is an opportunity to join a forward-thinking organization where innovation meets purpose and to play a key role in shaping the future of medical technology.
Position: The Medical Surgical Fiber Product 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 to verification and validation, and to transfer to manufacturing.
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 the 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.
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.
- Advanced project management skills, including reporting and presentation capabilities.
- Excellent written and verbal communication skills.
- 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
- 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.
