Director, Operations

About the role

Reporting to the General Manager, the Director of Operations is responsible for managing day-to-day operations and core functions to achieve and maintain operational excellence in a regulated manufacturing environment.

Responsibilities

• Guarantee production, delivery in full, on time, and to specifications required by customers at the most competitive cost.
• Define operational financial goals and maintain strong P&L ownership.
• Establish and communicate Business Unit goals and assignments.
• Define and execute operational programs aligned with strategic plans and annual operating goals.
• Meet with Executive Business at least monthly to review and evaluate key operational indicators (KOIs).
• Attend quarterly business reviews with key customers.
• Partner with other business units to establish strategic plans and goals.
• Direct and control activities in purchasing, production control, planning, manufacturing engineering, test engineering, maintenance, manufacturing, and logistics.
• Implement HR strategies to recruit and retain a qualified and motivated workforce.
• Lead multi-shift operations with a strong focus on safety, quality, and compliance.
• Oversee new product introductions (NPIs), process validation (IQ/OQ/PQ), and design transfer.
• Drive Lean Daily management and apply Lean tools to improve operational efficiency.

Requirements

• Bachelor’s degree required; MBA preferred.
• 10–15 years of manufacturing experience, with 3–5+ years in a Director-level Operations role within Medical Devices or other regulated industries.
• Proven experience leading operations under FDA, ISO 13485, GMP, and customer audits.
• Demonstrated success delivering measurable results while maintaining high quality and compliance standards.
• Hands-on experience with assembly, high-speed automation, and validated manufacturing processes.
• Deep experience managing NPIs, process validation (IQ/OQ/PQ), and design transfer.
• Ability to scale operations while maintaining patient safety and regulatory integrity.
• Strong cross-functional leadership with Quality, Engineering, Supply Chain, and Regulatory teams.

Skills

We are looking for a humble, secure, persistent, data-driven, and high-energy leader who is also a good mentor.

Location: Buffalo Grove, Illinois