About:
Epitope Diagnostics, Inc. is an ISO 13845 certified medical device manufacturing company in San Diego. We specialize in developing and manufacturing in-vitro diagnostic instruments and reagents for the global clinical and research laboratories.
Position Summary:
We are seeking a highly motivated Bioengineer or related field to support the installation, validation, and operation of our CLIA (Chemiluminescent Immunoassay) Analyzer ECL25 or ECL100. The successful candidate will work closely with the technical and production teams and will be in charge of installation, technical engineer training, run validation tests, application training, trouble shooting.
Key Responsibilities:
- Install, validate the analyzer in compliance with Epitope Diagnostics standards worldwide and ensure EDI CLIA kits work properly on the analyzer.
- Complete IQ, OQ, PQ and other protocols related to instrument/products. Collect validation data from the installed instrument.
- Collect kit validation data as requested by clinical laboratory. Serve as a liaison between Epitope and the laboratory.
- Properly deliver technical training sessions for engineers of laboratories, distributors and service companies for the analyzer.
- In charge of trouble shooting for the analyzer, replace parts and perform maintenance. Provide onsite or remote assistance to distributors and laboratory technicians.
- Must be able to travel domestically and internationally 30%-50%
- Draft necessary analyzer installation or maintenance protocols
- Work with the production team to understand reagent preparation and workflow.
- Provide feedback and support for the continuous improvement of lab operations and production integration.
- Perform quality control testing.
Qualifications:
- A minimum of a Bachelor's degree
- 2-year experience of diagnosing and repairing mechanical, electromechanical, robotics, electronic equipment, and/or instrumentation is preferred.
- Strong knowledge of electronics and mechanics.
- Strong knowledge of computer skills like Microsoft Offices and SQL Server and Database, LIS.
- Good communication and customer service skills.
- Ability to travel frequently.
- Experience with CLIA systems (e.g., Abbott, Siemens, Beckman Coulter, or similar immunoassay analyzers) is highly preferred but not needed.
- Strong analytical and problem-solving skills.
Preferred Skills:
- Understanding of immunoassay principles and in-vitro diagnostic product.
- Experience writing SOPs and equipment validation documents.
Job Type: Full-time
Pay: $65,000.00 - $80,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
Work Location: In person
