Jobs · Manufacturing · California

Electro-Mechanical Technician - Medical Device R&D

huMannity Medtec · Santa Clarita, CA · 1 mo ago
ManufacturingFull-time

About the role

We are seeking an experienced Electro-Mechanical Technician to support the research, development, testing, and manufacturing activities associated with implantable neuromodulation medical devices. The successful candidate will provide hands-on technical support to engineering teams responsible for the development and evaluation of implantable pulse generators (IPGs), stimulation leads, and associated test systems used in neuromodulation therapies.

Responsibilities

  • Assemble, modify, and test implantable pulse generators (IPGs), stimulation leads, and related neuromodulation systems.
  • Support bench, characterization, reliability, and design verification testing activities.
  • Execute engineering protocols and test methods with minimal supervision.
  • Collect, document, analyze, and report experimental data accurately and completely.
  • Generate test reports and summarize experimental results for engineering review.
  • Operate laboratory instrumentation including oscilloscopes, digital multimeters, power supplies, stimulation systems, and data acquisition equipment.
  • Perform troubleshooting and failure analysis of electro-mechanical assemblies and implantable medical device systems.
  • Build and maintain test fixtures, laboratory setups, and prototype assemblies.
  • Maintain laboratory notebooks and electronic records suitable for regulatory submissions.
  • Maintain traceability of test articles, samples, and experimental data.
  • Support incoming inspection, inventory control, and material management activities.
  • Work closely with Mechanical, Electrical, Manufacturing, Quality, and Regulatory Engineering teams.

Requirements

  • Associate degree in Electronics Technology, Mechanical Technology, Biomedical Engineering Technology, or related technical discipline.
  • Minimum 10 years of electro-mechanical technician experience.
  • Minimum 5 years of experience supporting medical device product development.
  • Strong hands-on experience with both mechanical and electrical assembly techniques.
  • Experience supporting research and development projects in a regulated environment.
  • Experience working with miniature components, cables, connectors, and implantable device assemblies.
  • Experience soldering and reworking electronic components under microscope inspection.
  • Ability to read and interpret engineering drawings, schematics, assembly procedures, and test protocols.
  • Strong troubleshooting and diagnostic skills.
  • Excellent documentation and technical communication skills.
  • Proficiency with Microsoft Office applications including Word, Excel, and PowerPoint.

Preferred Qualifications

  • Experience with implantable neuromodulation systems.
  • Experience with implantable pulse generators (IPGs).
  • Experience with stimulation lead assembly and testing.
  • Familiarity with ISO 14708 series standards.
  • Experience supporting regulatory submissions and design verification testing.
  • Experience with medical-grade adhesives, silicones, epoxies, and encapsulation materials.
  • IPC J-STD-001 and/or IPC-A-610 certification preferred.

Qualifications

  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • ISO 13485 Medical Devices Quality Management Systems
  • FDA Design Controls
  • Design History Files (DHF)
  • Device Master Records (DMR)
  • Data Integrity and Traceability Requirements

Work Environment

Full-time onsite position. Medical device research and development laboratory environment. Frequent use of microscopes, laboratory instrumentation, and prototype assembly equipment. No travel required.

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