Job description

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 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. 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. • 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. • 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. • 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. • 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. Required: • Bachelor's degree in a STEM related field • 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. Salary Range: $130,000 tp $160,000 depending on skills and experience • 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!!! Nextern is 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.

Requirements

Must-haves

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.
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.
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.
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.
Bachelor's degree in a STEM related field
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).
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.
$130,000 tp $160,000 depending on skills and experience
Retirement Plan with Company Match
Lifetime Membership Subsidy and Wellness Resources
Short-Term & Long-Term Disability
Taco Thursdays!!!

Nice-to-haves

8+ years of progressive manufacturing or process engineering experience, including 2+ years in a leadership role; medical device or regulated manufacturing strongly preferred.
Certifications preferred: Six Sigma Green Belt or Black Belt, Lean, or PMP.

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: workable
Effort: medium

Benefits

Benefits detected in the listing.

Dental

Vision

Paid Time Off

Wellness