Director of Operations

icotec is a fast-growing global company headquartered in Altstätten, Switzerland and Boston, Massachusetts that is reshaping today’s spine care and defining what the future of spinal implants will make possible.Using our proprietary BlackArmor®process technology, icotec pioneers radiolucent, nonmetallic spinal implant systems made of Carbon/PEEK. Designed and engineered specifically for patients with spinal tumors and complex spinal conditions, our implants empower visualization throughout the patient care pathway and improve biomechanics. This enables clearer imaging, more precise radiation therapy, and better-informed clinical decision making.At icotec, you will help shape how spinal tumors and complex diseases are treated, supporting in the treatment of today’s surgical spine patients. We value multi-disciplinary collaboration with leading spine surgeons, radiation oncologists, and the entire clinical care teams at renowned global institutions. In this role, you will contribute to a fast-evolving business at the intersection of material science and process technology.We are a Swiss, family-owned company with global reach defined by enthusiasm, responsible ownership, accountability, collaboration and purpose-driven work. As we continue to grow and expand globally, you will have the opportunity to take responsibility, shape your own career path, and be part of a category leading company. We take great pride in investing in our people with competitive benefits, including 100% company-paid health, dental, and vision coverage for U.S. employees.If you are looking to do meaningful work, move fast, and be part of a team redefining the future of spine care, welcome to your possible future home.

Join our passionate and innovative team as a

Director of Operations

Position Summary & Key Responsibilities

icotec is planning to open a US-based manufacturing operation in Boston, and we are looking for a hands-on operations leader to build it with us. The Director of Operations, US will own the full US operational value chain: procurement, manufacturing, supply chain, logistics, and customer service.This is a hands-on build role. You will start on the production floor, learning our products and processes from the ground up, then lead the site setup, production ramp-up, and future capacity expansion. Strong project management is central to success in this role: the site build-out is a multi-workstream program that you will plan, run, and deliver. You will work closely with our global Operations, Engineering, Quality, and R&D teams in Switzerland and serve as a member of the US leadership team. As the US business grows, the scope of this role will grow with it.

You willbe responsible for:

• Develop and execute the US operations strategy, aligned with global operations and US leadership, as part of the overall company objectives.
• Build scalable manufacturing processes and organizational structures that support future growth.Prepare and manage the annual US operations budget, including operating expenses and capital investment projects.
• Define, track, and deliver operational KPIs agreed with the COO and CEO US.Serve as an active member of the US leadership team and bring an entrepreneurial, solutions-focused mindset.

Operations and Value Chain

• Own the US operational value chain: procurement, manufacturing, supply chain, logistics, and customer service.
• Lead the setup and ongoing development of the Boston manufacturing site, including production ramp-up and future capacity expansion.
• Build local manufacturing capability and technical expertise in processes and infrastructure.Manage and mature the Sales & Operations Planning (S&OP) process.
• Ensure consistent product supply and availability, and improve productivity, inventory, lead times, and operational flexibility.

Project and Program Management

• Plan and manage the Boston site build-out as a formal program, covering facility readiness, equipment installation and qualification, process and technology transfer from Switzerland, and hiring.
• Own project scope, schedules, budgets, resources, risks, and milestones, using structured project management methods and tools.
• Coordinate work across US and Swiss teams and external vendors, contractors, and suppliers.Report progress, risks, and decisions clearly to the COO, CEO US, and leadership teams in both countries.
• Lead future capacity expansions and improvement projects with the same discipline.

Quality, Compliance, and Continuous Improvement

• Ensure compliance with FDA, ISO 13485, and all applicable company and regulatory requirements.
• Oversee validated manufacturing processes and qualified manufacturing equipment.
• Establish a continuous improvement culture using Lean and Six Sigma methods (e.g., 5S, value stream mapping, standard work, DMAIC, SPC).
• Drive performance improvement through CAPA, root cause analysis, and structured process optimization.

People and Organization

• Recruit, lead, coach, and develop the US operations team.
• Directly manage US Customer Service and Logistics, partnering in a matrix structure with functional leaders in Switzerland.
• Act as deputy for the future US Production Manager and US Procurement Manager as needed.
• Model icotec's values and its collaborative, non-hierarchical leadership style.
• Maintain clear internal and external communication and well-defined roles and responsibilities across the team.

You should bringthe following with you:

Required:

• Bachelor's degree in engineering, operations management, supply chain management, business administration, or a related field.
• 10+ years of experience in operations, manufacturing, or supply chain, including 5+ years in a people leadership role, ideally in an innovative medtech environment
• Experience working in a global or multinational company, including collaborating across countries in a matrix structure.
• Hands-on experience with injection molding, compression molding, and/or CNC machining.
• Proven experience building, scaling, or leading a manufacturing operation in a regulated environment.
• Experience with validated manufacturing processes, equipment qualification (IQ/OQ/PQ), and quality management systems.
• Track record managing budgets, operational KPIs, and capacity planning.
• Proven project and program management experience, including leading complex cross-functional projects (such as facility build-outs, equipment installation and validation, or technology transfers) on time and within budget.Strong communication, stakeholder management, analytical, and problem-solving skills.
• Willingness to work hands-on as part of the manufacturing team during the initial ramp-up period.
• Ability to spend an initial 2–3 months in Switzerland and to travel to Switzerland and other US sites as needed.
• Ability to obtain and maintain a valid passport and any travel documentation required for international travel.

Preferred:

• Experience in medical devices, life sciences, or another FDA-regulated industry.
• Working knowledge of FDA 21 CFR Part 820 (QMSR) and ISO 13485.Lean Six Sigma Green Belt or Black Belt certification, with a track record of measurable improvement results.
• Project Management Professional (PMP) or equivalent project management certification.
• Experience with greenfield site startups or new product transfers into manufacturing.
• Experience implementing or maturing an S&OP process and ERP/MRP systems.
• German language skills and experience working with Swiss or European teams.
• Advanced degree (MBA or MS in Engineering)

Additional Information:

Working Conditions and Physical RequirementsOn-site role in a manufacturing environment, including controlled production areas where applicable.Regular time on the production floor, especially during the initial ramp-up period.Ability to stand and walk for extended periods and lift up to 25lbs lbs.Use of personal protective equipment as required.An initial 2–3-month assignment in Switzerland, followed by ongoing international travel estimated at ~10% of the time.

Equal Opportunity & Accommodation:

icotec is an equal opportunity employer and considers qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other characteristic protected by applicable law. Applicants who require reasonable accommodation during the application or interview process may contact Human Resources.

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