Director, US Operations & Manufacturing

icotec; Boston (MA); On-site; USD 180,000 - 250,000; Full time

Benefits offered by this job

100% company-paid health, dental, and

Job summary

icotec, a Swiss family-owned company with a growing US footprint, is building a new Boston manufacturing site. We seek a hands-on Director of Operations to own the full US value chain from procurement to customer service.

Based in Boston, you will start on the production floor, lead site setup, ramp-up, and future capacity expansion, while aligning with global teams in Switzerland to deliver scalable operations under FDA/ISO 13485 compliance.

Qualifications

• Bachelor's degree in engineering, operations management, supply chain management, business administration, or 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 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Job description

icotec, a Swiss family-owned company with a growing US footprint, is building a new Boston manufacturing site. We seek a hands-on Director of Operations to own the full US value chain from procurement to customer service.

Based in Boston, you will start on the production floor, lead site setup, ramp-up, and future capacity expansion, while aligning with global teams in Switzerland to deliver scalable operations under FDA/ISO 13485 compliance.