Sr. Manufacturing Engineer

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

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Wellness Resources

Retirement Plan with Company Match

Paid Time Off, Personal Days, AND

Birthday Holiday

Life Insurance

Family Leave

Disability Insurance

Taco Thursdays!!!

Job summary

Nextern seeks a Senior Manufacturing Engineer with 7–10 years in medical device manufacturing, focusing on catheter and balloon catheter processes such as balloon forming, extrusion, tipping, bonding, and related assembly. The role is a technical leader with no direct reports.

You will drive process development, design transfers, and validation activities using DOE, SPC, and lean methodologies to improve first-pass yield and throughput, while mentoring junior engineers and ensuring regulatory

Qualifications

• Bachelor's degree in a STEM field; Master’s a plus.
• 7+ years in medical device manufacturing engineering with catheter/balloon experience.
• Experience with FDA-regulated manufacturing, process validation, and design transfers.
• Advanced CAD skills and SPC/DOE lean methods; IQ/OQ/PQ exposure.

Responsibilities

• Serve as senior SME for catheter/balloon manufacturing incl. forming, extrusion, tipping, bonding, and RF/laser welding.
• Design, develop, and optimize complex manufacturing processes; apply DOE and lean to improve yield.
• Lead manufacturing readiness activities and transfer designs to scalable production.
• Create and approve procedures, risk analyses, and validation protocols per FDA/ISO.
• Lead validation strategy for new equipment and processes; mentor junior engineers.
• Coordinate with QA, Regulatory, R&D, and suppliers on qualifications.
• Ensure compliance with FDA 21 CFR Part 820 and ISO 13485.

Skills

Catheter/balloon manufacturing

Manufacturing engineering

DOE/DOE methods

SPC

Lean manufacturing

Root cause analysis

ERP systems (Epicor)

CAD (SolidWorks/AutoCAD)

FDA regulatory experience

Education

Bachelor's degree in STEM

Master's degree a plus

Tools

SolidWorks

AutoCAD

Epicor ERP

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.