Sr. Manufacturing Engineer
Nextern
Summary
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.
Job description
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.
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.
Requirements
- Bachelor's degree in a STEM related field
- 7+ years of experience in medical device manufacturing engineering
- Hands-on experience with catheter and balloon catheter manufacturing (balloon forming/blow molding, extrusion, tipping, bonding)
- 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
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Time Off
- Personal Days
- Birthday Holiday
- Lifetime Membership Subsidy
- Wellness Resources
- Life Insurance
- Family Leave
- Short-Term Disability
- Long-Term Disability
- Taco Thursdays
Company overview
Nextern is a collaborative medical device company that specializes in end-to-end medical device product design, development, and manufacturing. Headquartered in Maple Grove, Minnesota, the company operates as a strategic partner for innovators, clinicians, and device companies seeking to accelerate their commercial success. Nextern brings an unmatched core competence in medical device engineering, with expertise spanning from initial concept through full-scale production. The company's capabilities include catheter design, structural heart technologies, neurostimulation systems, wireless connected devices, and surgical robotics. With ISO 13485 certification and FDA registration, Nextern maintains global manufacturing facilities across the United States, Costa Rica, Vietnam, and China, providing flexible production solutions tailored to specific client requirements. The company's unique business model treats clients as collaborators rather than customers, investing in design and development services to build long-term manufacturing partnerships. Nextern's technical expertise covers advanced materials including Nitinol, stainless steel, platinum iridium, and other biocompatible alloys, with specialized capabilities in laser cutting, welding, braiding, and post-processing for complex medical device applications.