Medical Surgical Fiber Product Engineering Manager

Location: Marlborough, MA
Salary: $150,000.00 USD Annually - $180,000.00 USD Annually
Description:
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

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Contact:

This job and many more are available through The Judge Group. Please apply with us today!

Salary : $150,000 - $180,000