Medical Product Engineering Manager
The Medical Product Engineering Manager leads R&D activities for all medical fiber products, focusing on innovation, reliability, and alignment with company strategy. This role manages the full product development lifecycle-from defining requirements and design outputs through verification, validation, and transfer to manufacturing.
Key Responsibilities
- Identify opportunities for innovation in product design, manufacturing, and testing
- Manage the internal fiber component portfolio to ensure lifecycle alignment, standardization, reuse, and cost efficiency
- Drive internal innovation to improve performance, manufacturability, and cost-effectiveness
- Serve as the primary technical point of contact for external vendors and customers
- Oversee budgets, resources, and timelines to ensure on-time, cost‑effective project delivery
- Meet performance, quality, and cost goals while reducing development cycle time through process improvements
Requirements
- Bachelor's degree in engineering; Master's preferred
- Minimum 10 years of R&D experience with fiber-based medical products
- At least 5 years managing engineering teams within ISO 13485/FDA‑regulated environments, from design input through production transfer
- Strong project management, reporting, and presentation skills
- Excellent written and verbal communication abilities
- Hands‑on experience with optical, electrical, mechanical, and electronic lab work involving medical fiber products
- Proven track record delivering complex, cross‑functional projects on time and within budget
- Ability to manage multiple projects in a fast‑paced environment
- Experience working within controlled product development processes
- Knowledge of Design Controls, Risk Management, and relevant standards (e.g., FDA QSR, ISO 13485, EU MDR, ISO 14971, IEC 60601/60825/62366) preferred
FAQs
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