Manufacturing Engineer Tech II- 2nd Shift

Nextern is seeking a versatile, hands-on Manufacturing Engineering Technician who can work across both sides of our product portfolio: complex electromechanical devices — consoles, capital equipment, and their supporting test systems — and precision single-use disposables, specifically catheter and balloon catheter systems. This combined role exists because our programs increasingly pair a capital console with a disposable, and we need technicians who can support the full system rather than one half of it.

This is not an entry-level position. The successful candidate will have a minimum of 5 years of hands-on technician experience in a regulated manufacturing environment and will work with limited supervision — building and debugging electromechanical assemblies, running electrical safety and automated functional test stations, executing catheter and balloon processes to tight tolerances, supporting equipment qualifications, and investigating returned product. The technician serves as a direct extension of the manufacturing engineering team on the floor and is often the first person to touch a problem.

Nextern operates a global manufacturing footprint, and this role supports process transfer, station replication, and build support with our Costa Rica, China, and Vietnam sites.

Requirements

DUTIES AND RESPONSIBILITIES

Electromechanical & Capital Equipment Build

• Console and Capital Equipment Assembly: Build, integrate, and debug consoles, capital equipment, and complex electromechanical assemblies — including enclosures, power supplies, motion and pneumatic subsystems, wire harnesses, and cable assemblies — working from large multi-level bills of material and multi-operation routings
• Electronics and PCBA Handling: Handle, install, and troubleshoot printed circuit board assemblies (PCBAs) and electronic subassemblies; perform and inspect solder and rework operations to IPC-A-610 and J-STD-001 workmanship criteria; build and inspect cable and harness assemblies per IPC/WHMA-A-620; maintain ESD controls per ANSI/ESD S20.20
• Firmware and Configuration: Execute firmware loading, device programming, configuration, and serialization steps at the station level, and verify results against the traveler and device history record
• First Article and Pilot Builds: Support first-article, prototype, and pilot builds; capture build issues, cycle times, and process feedback for engineering; assist in refining work instructions before production release

Electrical Safety & Automated Test

• HIPOT and Electrical Safety Testing: Set up, operate, and troubleshoot electrical safety test stations — dielectric withstand (HIPOT), insulation resistance, ground bond / protective earth continuity, and leakage current — following defined parameters and safety controls, and escalating failures with clear technical documentation
• Automated and Functional Test Systems: Operate, maintain, and debug automated test equipment (ATE), functional test stands, and end-of-line test systems; diagnose fixture, cabling, instrumentation, and unit-under-test failure modes; support test station replication, setup, and periodic verification
• Electronic Troubleshooting: Use multimeters, oscilloscopes, power supplies, and data acquisition equipment to isolate faults down to the component, connector, or subassembly level; read and work from electrical schematics, wiring diagrams, and interconnect drawings

Catheter & Balloon Manufacturing

• Catheter Processing: Perform catheter shaft preparation including cutting, grinding, skiving, and surface treatment; execute tip forming operations using heat forming equipment; apply radiopaque marker bands using precision placement fixtures and bonding techniques; support extrusion operations for multi-lumen tubing
• Balloon Operations: Perform balloon bonding (proximal and distal), folding, and wrapping using manual and semi-automated equipment; inspect balloons for pinholes, wrinkles, and dimensional nonconformance
• Catheter Assembly: Assemble complete catheter systems including hubs, strain reliefs, guidewire lumens, hemostasis valves, and Luer fittings using adhesive bonding, thermal bonding, and mechanical crimping operations
• Disposable Functional Testing: Conduct burst pressure and rated burst pressure verification, leak testing, compliance testing, and tensile and bond strength testing using pull testers; document all results in batch records and ERP

Equipment Qualification, Maintenance & Metrology

• Qualification Execution: Execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols on new and existing manufacturing and test equipment; document results meticulously and compile clear reports for engineering review
• Preventive Maintenance and Calibration: Perform routine preventive maintenance on assembly, test, and catheter processing equipment; manage calibration schedules for measurement and test equipment; coordinate repairs with maintenance, engineering, and vendors
• Inspection and Measurement: Perform in-process and final dimensional inspection using calipers, micrometers, optical comparators, and microscopes; conduct visual inspection under magnification against defined acceptance criteria

Returned Product, Documentation & Compliance

• Returned Product Analysis: Manage the returned product process — receiving, decontamination, functional and physical evaluation, and initial investigation — and provide precise, well-documented findings to Quality and Engineering to support complaint investigations and product improvement
• ERP Transactions: Use Epicor ERP for work order processing, material transactions, labor reporting, inventory management, and BOM and routing verification against the physical build
• Documentation: Complete device history records, travelers, batch records, and test data accurately and legibly; draft and red-line work instructions and procedures for engineering review; support deviation and nonconformance investigations and corrective actions
• Regulatory Adherence: Work in full compliance with FDA 21 CFR Part 820, ISO 13485, and cGMP requirements, including DHF and DMR expectations

Cleanroom, Continuous Improvement & Team Support

• Controlled Environments: Maintain and operate equipment within Class 7/8 cleanroom environments, adhering strictly to gowning, cleaning, and contamination control procedures; monitor and document environmental conditions
• Continuous Improvement: Partner with engineers to identify process improvements, fixture and tooling enhancements, error-proofing opportunities, yield gains, and cycle time reductions; build and modify simple fixtures as directed
• Training and Support: Train and support operators and newer technicians on assembly, test, and catheter processes; serve as a floor-level technical resource across both product families
• Other duties and projects as assigned, including potential travel to international manufacturing sites (Costa Rica, China, Vietnam)

Qualifications

Education

• High school diploma or GED required
• Associate degree in a technical field strongly preferred — Electronics Technology, Electromechanical or Mechatronics Technology, Biomedical Equipment Technology, Manufacturing Technology, Polymer Science, or similar
• Military technical training (electronics, avionics, biomedical equipment) or certificate programs in medical device or catheter manufacturing are considered equivalent and are welcomed

Experience (Required)

• Minimum 5 years of hands-on technician experience in medical device or comparably regulated manufacturing. This is not an entry-level position
• Demonstrated depth in at least one of the two core domains — (a) electromechanical / capital equipment build and test, or (b) catheter and balloon manufacturing — with working proficiency and clear aptitude in the other. Candidates with genuine hands-on depth in both will be prioritized and considered at the upper end of the compensation range
• Hands-on experience executing equipment qualifications (IQ/OQ) and writing clear technical reports
• Proven experience troubleshooting to root cause using both hand tools and electronic test equipment
• Prior experience working in a Class 7/8 cleanroom environment
• Working knowledge of Epicor or a similar ERP / manufacturing execution system

Experience (Preferred)

• Direct experience with HIPOT / dielectric withstand, ground bond, and leakage current testing
• Experience operating or maintaining automated test equipment or functional test stands
• Experience with interventional or vascular catheters, balloon catheter systems, or similar single-use disposables
• Contract manufacturing (CDMO/CMO) experience supporting multiple customers and programs concurrently
• IPC certification (IPC-A-610, J-STD-001, or IPC/WHMA-A-620)
• Experience supporting builds or process transfer at offshore manufacturing sites

Technical Skills — Electromechanical & Test

• Ability to read and work from electrical schematics, wiring and harness diagrams, interconnect drawings, and mechanical prints
• Proficiency with electronic test and measurement equipment: multimeters, oscilloscopes, power supplies, HIPOT testers, and data acquisition systems
• Soldering, rework, crimping, and cable and harness build skills to recognized workmanship standards
• Understanding of ESD control requirements and proper handling of electronic assemblies
• Comfort navigating large, multi-level BOMs and multi-operation routings and identifying discrepancies between documentation and the physical build

Technical Skills — Catheter & Balloon

• Proficiency in catheter processes including extrusion support, heat and tip forming, skiving, bonding, and coating applications
• Hands-on capability with balloon forming, folding techniques, and balloon-to-catheter bonding
• Experience operating pull testers, burst pressure testers, and leak testers
• Proficiency with precision hand tools including scalpels, crimpers, heat guns, and torque drivers
• Skilled use of micrometers, calipers, optical comparators, and microscopes for dimensional verification and defect detection under magnification

Regulatory Knowledge

• Strong working understanding of FDA 21 CFR Part 820 Quality System Regulation and cGMP requirements
• Familiarity with ISO 13485 Medical Device Quality Management System
• Understanding of Design History File (DHF) and Device Master Record (DMR) requirements
• Awareness of IEC 60601-1 electrical safety requirements as they drive production test, and ISO 10993 biocompatibility requirements for patient-contacting materials

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.