Medical Surgical Fiber Product Engineering Manager

Position Overview

The Engineering Manager will lead all research and development efforts for the company’s medical fiber product portfolio, with a strong emphasis on innovation, product reliability, and alignment with strategic business goals. This role oversees the full product design lifecycle—from defining design inputs and outputs, through verification and validation, to successful transfer into manufacturing. The ideal candidate brings deep technical expertise in fiber‑based medical technologies and a proven track record of leading engineering teams in regulated environments.

Key Responsibilities

• Identify opportunities for innovation in fiber design, manufacturing processes, and product testing.
• Manage the internal fiber component portfolio, ensuring lifecycle alignment, standardization, reuse, and cost efficiency.
• Drive internal R&D initiatives to enhance performance, manufacturability, and cost‑effectiveness of fiber products.
• Serve as the primary technical point of contact for external vendors and customers, ensuring clear, effective communication.
• Manage budgets, resources, project schedules, and cross‑functional coordination to ensure timely and cost‑efficient delivery.
• Meet quality, performance, and cost benchmarks while reducing development cycle times through process and workflow improvements.

Requirements

Education & Experience

• Bachelor’s degree in an Engineering discipline; Master’s degree preferred.
• Minimum 10 years of R&D experience in fiber‑based medical products.
• At least 5 years of engineering team leadership in ISO 13485 and FDA‑regulated organizations, managing the full lifecycle from design input through production transfer.

Technical & Leadership Skills

• Strong project management skills, including reporting, documentation, and executive‑level presentations.
• Excellent written and verbal communication abilities.
• Hands‑on experience with optical, electrical, mechanical, and electronic lab experimentation involving fiber‑based medical devices.
• Proven record of delivering complex, cross‑functional projects on time and within budget.
• Ability to manage multiple concurrent projects in a fast‑paced environment.
• Demonstrated experience in controlled product development processes.
• Knowledge of Design Controls, Risk Management, and key regulatory standards including:
  • FDA QSRs
  • ISO 13485
  • EU MDR
  • ISO 14971
  • IEC 60601, IEC 60825, IEC 62366