Sr. Manufacturing Engineer

Nextern; Maple Grove (MN); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Retirement Plan with Company Match

Paid Time Off, Personal Days, AND生日假期

Lifetime Membership Subsidy andWelln

Life Insurance (Basic, Voluntary &

Family Leave (Maternity, Paternity)

Short-Term & Long-Term Disability

Taco Thursdays!!!

Job summary

Nextern is seeking a Senior Manufacturing Engineer with deep hands-on expertise in catheter and balloon catheter manufacturing to lead high-risk processes and drive continuous improvement. This individual will act as a senior technical authority, mentor junior engineers, and partner with R&D during transfers to scalable production.

The role requires 7–10 years in medical device manufacturing, with a focus on balloon forming, extrusion, tipping, bonding, and related assembly operations.

Qualifications

• 7+ years in medical device manufacturing engineering with catheter/balloon experience.
• Hands-on leadership in high-risk manufacturing processes and validation.
• Experience with FDA-regulated environments and design transfers.

Responsibilities

• Lead catheter/balloon manufacturing processes including forming, extrusion, tipping, bonding and RF/laser welding.
• Design, develop and optimize complex manufacturing processes for electro-mechanical devices using DOE/DOE and lean methods.
• Own validation strategy (IQ/OQ/PQ) and equipment qualification for new and existing processes.

Skills

Catheter manufacturing

Balloon catheter manufacturing

DOE

SPC

Lean manufacturing

IQ/OQ/PQ validation

CAD software

FDA compliance

Education

Bachelor's degree in STEM

Master's degree (a plus)

Tools

Epicor ERP

SolidWorks/AutoCAD

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.

We are seeking a Senior Manufacturing Engineer with deep, hands-on expertise in medical device manufacturing to serve as a technical leader within our manufacturing organization. The ideal candidate will have 7-10 years of experience in medical device manufacturing engineering, with demonstrated, specific expertise in catheter and balloon catheter manufacturing processes (including balloon forming, catheter shaft extrusion, tipping, bonding, and related assembly operations). This role acts as the senior technical authority on complex, high-risk manufacturing processes, driving process development, transfer, and continuous improvement independently and with minimal oversight, while mentoring junior engineers on catheter and balloon-specific manufacturing techniques. This is an individual-contributor role with no formal direct reports.

RESPONSIBILITIES

• Serve as the senior subject-matter expert for catheter and balloon catheter manufacturing, including balloon forming/blow molding, compliance and burst testing, extrusion, tipping, skiving, marker band placement, shaft bonding, and RF/laser welding processes.
• Independently design, develop, and optimize complex manufacturing processes for electro-mechanical devices and single-use disposable products, applying DOE, SPC, and lean methodologies to drive first-pass yield and throughput improvements.
• Lead manufacturing readiness activities for new catheter and balloon-based products, partnering with R&D to transfer designs from development into scalable, validated production.
• Author and approve manufacturing procedures, work instructions, SOPs, and process specifications; lead risk analysis, DHF contributions, and validation/verification protocols in compliance with FDA regulations and ISO 13485.
• Lead the design, development, and qualification of manufacturing fixtures, tooling, and semi/fully-automated equipment for catheter and balloon assembly, ensuring compliance with design controls.
• Own and lead IQ/OQ/PQ validation strategy and execution for new and existing catheter/balloon manufacturing processes and equipment.
• Lead complex root cause investigations, drive corrective and preventive actions (CAPA), and champion continuous improvement initiatives across the production floor.
• Utilize and oversee accuracy of the Epicor ERP system for Bills of Materials (BOMs), routing operations, work orders, inventory management, and production planning.
• Act as the primary manufacturing engineering point of contact with Quality Assurance, Regulatory Affairs, R&D, and key suppliers on catheter/balloon component and material qualification.
• Ensure all manufacturing processes comply with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable medical device regulations.
• Mentor and train junior and mid-level manufacturing engineers and production personnel on catheter/balloon manufacturing techniques, process troubleshooting, and best practices, without formal supervisory authority.
• Serve as the escalation point for complex production floor issues, troubleshooting and implementing solutions to maintain production schedules and quality targets.

Requirements

QUALIFICATIONS

• Bachelor's degree in a STEM related field. Master's degree a plus.
• 7+ years of experience in medical device manufacturing engineering, including significant, hands-on experience with catheter and balloon catheter manufacturing (balloon forming/blow molding, extrusion, tipping, bonding, and related processes)
• Proven experience with electro-mechanical device assembly and testing.
• Demonstrated experience with Epicor ERP or similar ERP software.
• Extensive experience in FDA-regulated manufacturing environments, including leading process validations and design transfers.
• Advanced proficiency in CAD software (SolidWorks, AutoCAD, or similar); strong command of statistical process control (SPC), Design of Experiments (DOE), and lean manufacturing principles; deep understanding of medical device design controls and validation processes; extensive experience leading IQ/OQ/PQ process validation.
• Thorough understanding of FDA 21 CFR Part 820 Quality System Regulation; expert knowledge of ISO 13485; strong familiarity with ISO 14971 Risk Management; solid understanding of ISO 10993 biocompatibility requirements.

Salary range: $100,000 to $130,000 based on skills and experience

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!!!

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.