Manufacturing Manager

Nextern; Maple Grove (MN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health Plan

Retirement match

Paid time off

Birthday holiday

Lifetime membership subsidy

Wellness resources

Life insurance

Family leave

Disability (short/long-term)

Taco Thursdays

Job summary

Nextern in Maple Grove, MN, seeks a Manufacturing Manager to lead a diverse production team responsible for on-time, compliant medical device manufacturing. You will drive throughput, capacity, and continuous improvement while aligning with quality and cost targets.

Primary duties include supervision of supervisors and operators, KPI ownership, and cross-functional collaboration with engineering, quality, and supply chain to ensure successful commercial production and product transfers.

Qualifications

• Bachelor's degree in engineering or related field.
• 8+ years in manufacturing operations with 3+ years supervising teams.
• Experience meeting schedule, quality, and cost targets in a high‑mix, low‑to‑mid volume environment.
• Working knowledge of 21 CFR Part 820 and ISO 13485 is preferred.

Responsibilities

• Lead daily manufacturing operations across assembly and production lines, including scheduling and staffing to meet commitments.
• Supervise, train, and develop production staff; set objectives and manage performance.
• Own KPIs (safety, on-time delivery, yield, scrap) and drive corrective actions.
• Support transfer of new products into production and respond to issues with CAPA.

Skills

Leadership

Ops management

Process improvement

Problem solving

Data-driven decisions

Education

Bachelor's degree in engineering or related field

Tools

ERP/MRP systems

Microsoft Excel

Job description

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.

DUTIES AND 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.

Production Execution & Capacity

• 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.

Quality, Cost & Problem Resolution

• 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.

Compliance & Continuous Improvement

• 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.

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.
• Perform other related duties as assigned by management.

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Taco Thursdays!!!

Nexternis an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.