Manufacturing Engineering Lead — Medical Devices

Nextern; Maple Grove, Northern (MN, KY); Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health plan

Retirement plan

Paid time off

Birthday holiday

Life insurance

Disability insurance

Family leave

Taco Thursdays

Job summary

Nextern’s Maple Grove facility seeks a Manufacturing Engineering Manager to lead the engineering team supporting new product introduction, transfer, and sustaining efforts for commercial production. The role emphasizes compliant, cost-effective processes at a US medical device CDMO site.

You will drive process development, automation, and validation, while mentoring engineers and aligning with quality and program management to meet schedules and transfer milestones.

Qualifications

• Bachelor's degree in mechanical/manufacturing/biomedical or industrial engineering or related field.
• 8+ years of manufacturing or process engineering experience.
• 2+ years in a leadership role; medical device/regulatory manufacturing preferred.
• Experience transferring products to manufacturing including IQ/OQ/PQ and test method validation.
• Hands-on automation, tooling/fixture design, and equipment qualification; CAD proficiency.

Responsibilities

• Lead daily manufacturing engineering activities for commercial production lines.
• Supervise, train, and develop manufacturing and process engineers and technicians.
• Establish and track KPIs (FYG, scrap, OEE, cycle time) and drive corrective actions.
• Partner with operations, quality, program management, and customers to support production schedules and transfers.

Skills

Manufacturing engineering

Leadership

Process development

Automation

CAD (SolidWorks)

IQ/OQ/PQ

Six Sigma

Statistics

CAPA

Communication

Education

Bachelor's degree in engineering

Advanced degree preferred

Tools

SolidWorks

Minitab

Job description

Nextern’s Maple Grove facility seeks a Manufacturing Engineering Manager to lead the engineering team supporting new product introduction, transfer, and sustaining efforts for commercial production. The role emphasizes compliant, cost-effective processes at a US medical device CDMO site.

You will drive process development, automation, and validation, while mentoring engineers and aligning with quality and program management to meet schedules and transfer milestones.