Operations Lead

Operations Lead – Medical Device CDMO (Multi-Site Operations, Minnesota)

A well-established and fast-growing medical device CDMO with end-to-end manufacturing capabilities is seeking a hands-on Operations Lead to take charge of performance across two U.S. sites. This is a Minnesota-based role with oversight of a second site, reporting to the regional General Manager.

This is a true shop-floor leadership role, ideal for someone with a strong lean background who turns priorities into clear daily plans and builds teams that reliably hit their customer commitments. There's real intention for this person to move into larger, more senior positions as the business scales.

• Lead day-to-day operations across two sites, covering safety, quality, delivery, cost, productivity, inventory and engagement.
• Directly lead production supervision, manufacturing and engineering teams.
• Run daily, weekly and monthly operating rhythms to track performance, elevate issues early and follow through on corrective actions.
• Drive continuous improvement and operational excellence to improve efficiency, yield, flow and labour productivity.
• Support new product introductions, equipment and technology adoption, and scaling efforts.
• Influence supply chain, quality, HR, finance and IT through dotted-line relationships to protect schedules and customer delivery.
• Spot risks, capacity constraints and resource gaps early and put mitigation plans in place.
• Coach and develop frontline leaders, and build a safety-first, quality-driven culture.

• 10+ years of progressive manufacturing or operations experience, including 5+ years leading production, operations or engineering teams.
• Proven track record of improving performance through lean, continuous improvement and quality systems.
• Working knowledge of regulated medical device environments, such as FDA, ISO 13485 and GMP.
• Experience influencing cross-functional, matrixed teams and driving accountability outside your direct line.
• Strong grasp of cost drivers, labour planning and performance metrics, with a data-driven approach.
• Bachelor’s degree, ideally in Engineering, Operations, Business or Supply Chain;
  Lean/Six Sigma Green Belt or above preferred.
• Must be based in Minnesota.

A high-impact opportunity for a driven operations leader to shape multi-site performance, with genuine career growth, within a fast-growing medical device organisation. A competitive package is on offer, in line with experience.