The Operations Technician will play a key role in supporting new product introductions (NPI) and sustaining activities for existing medical devices. This hands‑on role involves assembling, testing, and troubleshooting devices, as well as assisting with manufacturing processes, quality checks, and documentation. The ideal candidate is detail‑oriented, adaptable, and comfortable working in a dynamic startup environment.
This Medical Device Company, based in Los Angeles, is developing breakthrough neuromodulation devices and bioelectronic medicine to treat diseases and injuries that are incurable with conventional pharmacological agents. We are building a cohesive team with complementary and multidisciplinary expertise to develop and bring our products to market.
Key Responsibilities
New Product Development (Primary Focus): Assist in assembling and testing prototypes and pre‑production devices.
Support NPI activities including process setup, equipment validation, and first‑article builds.
Document assembly procedures, test results, and deviations according to quality standards.
Identify and report process issues or product defects during NPI activities.
Sustaining & Post‑Market Support: Perform hands‑on troubleshooting and repairs for existing products.
Conduct routine inspections, calibrations, and preventive maintenance on production equipment.
Support product changes and updates while ensuring compliance with regulatory and quality standards.
Assist in implementing corrective and preventive actions (CAPA) for operational issues.
Operational Support: Maintain a clean, organized, and compliant workspace following GMP/ISO standards.
Collaborate with cross‑functional teams including engineering, quality, and regulatory to ensure smooth operations.
Assist in inventory management and material preparation for manufacturing and testing.
Support continuous improvement initiatives to optimize efficiency and product quality.
Manufacturing & Design Transfer: Support design transfer to manufacturing, including pilot builds and production ramp‑up.
Work closely with Manufacturing and Supply Chain to resolve production issues and improve yield.Support supplier selection, qualification, and ongoing supplier management.
Qualifications
Associate degree or technical certification in manufacturing, biomedical engineering, or a related field (or equivalent hands‑on experience).
2+ years of experience in medical device assembly, operations, or technical support.
Familiarity with FDA 21 CFR Part 820, ISO 13485, and GMP practices.
Strong attention to detail and manual dexterity for assembly and testing tasks.
Excellent communication and teamwork skills; comfortable in a fast‑paced startup environment.
Experience in NPI or sustaining roles for medical devices.
Experience with bench testing, assembly of electronic or mechanical devices, and troubleshooting.
Knowledge of cleanroom practices and equipment maintenance.
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Operations Technician
Confidential · Los Angeles, CA, USA ·
- Job type:
- Full Time
About Confidential
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