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.