The Manufacturing Engineering Manager leads the manufacturing engineering team supporting new product introduction and transfer, process development and validation, automation, and sustaining engineering at Nextern's US medical device CDMO site, delivering capable, compliant, and cost-effective manufacturing processes in support of commercial production at the Maple Grove facility.
RequirementsDUTIES AND RESPONSIBILITIES:
• Lead daily manufacturing engineering activities, including process development, equipment and tooling support, automation, and sustaining engineering for commercial production lines.
• Supervise, train, and develop manufacturing and process engineers and engineering technicians; set objectives and manage performance.
• Establish and track KPIs (first pass yield, scrap and rework, OEE, cycle time, on-time completion of engineering deliverables) and drive corrective actions.
• Partner with operations, quality, program management, and customers to support commercial production schedules and product transfer milestones.
• New Product Introduction & Transfer
Lead transfer of customer designs into commercial production, including process development, tooling and fixturing, line layout, and capacity planning.
• Own process characterization and validation (IQ/OQ/PQ), test method validation, and pFMEA and control plan development.
• Provide design for manufacturability (DFM) feedback to customers and internal design teams during development.
• Process & Equipment Engineering
• Specify, qualify, and maintain manufacturing equipment, automation, tooling, and fixtures; manage capital projects from justification through installation and qualification.
Drive process capability improvements using statistical methods (SPC, Cp/Ppk, DOE) to reduce variation, scrap, and rework.
• Provide technical troubleshooting for production issues, nonconformances, and CAPA investigations; implement effective root cause corrective actions.
• Compliance & Continuous Improvement
• Ensure processes, validations, 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 engineering staff, including manufacturing and process engineers, automation engineers, and engineering technicians. Responsibilities include hiring, training, scheduling, performance management, and development in accordance with company policies and applicable laws.
QUALIFICATIONS:
• Bachelor's degree in mechanical, manufacturing, biomedical, or industrial engineering, or a related technical field required; advanced degree a plus.
• 8+ years of progressive manufacturing or process engineering experience, including 2+ years in a leadership role; medical device or regulated manufacturing strongly preferred.
• Demonstrated experience transferring new products into commercial production, including process development, process validation (IQ/OQ/PQ), and test method validation.
• Hands-on experience with automation, tooling and fixture design, and equipment qualification; CAD proficiency (SolidWorks or equivalent).
• 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 design controls, risk management (ISO 14971), pFMEA, and CAPA.
• Strong statistical, problem-solving, and communication skills; proficiency with Minitab or equivalent and data-driven decision making.
• Perform other related duties as assigned by management.
Benefits- 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!!!
