Manufacturing Manager

At Nextern, we inspire with passion, impact with significance, and act with integrity.. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.

The Manufacturing Manager leads the manufacturing operations team responsible for the safe, compliant, and on-time production of medical devices at Nextern’s US medical device CDMO site, managing production supervisors, leads, and assemblers to deliver to schedule, quality, and cost targets while continuously improving throughput and capacity at the Maple Grove facility.

Responsibilities:

• Lead daily manufacturing operations across assembly and production lines, including scheduling, staffing, throughput, and on-time delivery to customer commitments.
• Supervise, train, and develop production supervisors, team leads, assemblers, and operators; set objectives and manage performance.
• Establish and track KPIs (safety, on-time delivery, first pass yield, scrap and rework, labor efficiency, OEE) and drive corrective actions.
• Partner with manufacturing engineering, quality, supply chain, program management, and customers to support commercial production schedules and product transfer milestones.
• Own execution of daily and weekly production plans, including line loading, labor allocation, and overtime, to meet build schedules and revenue targets.
• Manage capacity, staffing models, and cross-training plans to support demand changes and new program launches.
• Support transfer of new products into commercial production, including operator training, work instruction readiness, and pilot and validation builds.
• Own manufacturing cost performance, including labor variance, scrap, and material usage; identify and execute cost reduction actions.
• Ensure production documentation, device history records, and training records are complete, accurate, and right the first time.
• Lead response to production issues and nonconformances; participate in CAPA investigations and implement effective root cause corrective actions.
• Ensure manufacturing operations, processes, and records comply with 21 CFR Part 820, ISO 13485, GDP, and site EHS/safety policies; support internal, customer, and regulatory audits.
• Apply lean, 5S, and Six Sigma principles to improve manufacturing flow, reduce cost, and increase throughput and capacity.
• SUPERVISORY RESPONSIBILITIES: Directly supervises manufacturing operations staff, including production supervisors, team leads, assemblers, and operators. Responsibilities include hiring, training, scheduling, performance management, and development in accordance with company policies and applicable laws.

Requirements

QUALIFICATIONS:

• Bachelor's degree in engineering, operations management, business, or a related field required; advanced degree a plus.
• 8+ years of progressive manufacturing operations experience, including 3+ years directly supervising production teams; medical device or regulated manufacturing strongly preferred.
• Demonstrated experience managing production to schedule, quality, and cost targets in a high-mix, low-to-mid volume manufacturing environment.
• Hands-on experience with production planning, capacity and labor models, and ERP/MRP systems; proficiency with Microsoft Excel.
• Certifications preferred: Six Sigma Green Belt or Black Belt, Lean, or PMP.
• Working knowledge of 21 CFR Part 820, ISO 13485, and Good Documentation Practices; experience with production documentation, device history record review, nonconformance, and CAPA processes.
• Strong leadership, problem-solving, and communication skills; able to use production data to drive daily decisions and hold teams accountable.