Senior R&D Technician – Medical Devices (Instruments)

Calyxo, Inc.; Pleasanton (CA); On-site; USD 56,000 - 62,000; Full time

Benefits offered by this job

Stock options

Healthcare insurance

Paid vacation

401(k)

Job summary

Calyxo, Inc. in Pleasanton, CA, is seeking a Senior R&D Technician to provide hands-on support in design, testing, and manufacturing of innovative medical devices. You will build prototypes, run tests, and help bring products from concept to launch.

Reporting to the Director of Instruments Engineering, you will collaborate with R&D, engineering and manufacturing teams, maintain equipment, perform IQ/OQ/PQ validation, and ensure compliance with ISO 13485 and FDA 21 CFR Part 820.

Qualifications

• 8+ years experience in a medical device, biotech or other regulated field.
• Associate degree or technical certification in biomedical or mechanical engineering or related field.
• Prototyping hands-on and basic shop tools experience.

Responsibilities

• Support product development by building prototypes, conducting tests, and documenting results in collaboration with R&D and engineering teams.
• Support process development through hands-on prototyping and problem solving.
• Perform root cause analysis of technical issues and recommend corrective actions.
• Maintain lab equipment, fixtures, and tools to ensure consistent performance.
• Assist in validation activities including IQ/OQ/PQ and design verification testing.
• Support manufacturing transfer activities including pilot builds and process documentation.
• Ensure compliance with company quality systems (e.g., ISO 13485, FDA 21 CFR Part 820).

Skills

Hands-on prototyping

Reading engineering drawings

Problem solving

GDP (Good Documentation Practices)

Education

Associate degree or technical certification in biomedical/ mechanical engineering

Tools

SolidWorks

CAD software

Job description

Calyxo, Inc. in Pleasanton, CA, is seeking a Senior R&D Technician to provide hands-on support in design, testing, and manufacturing of innovative medical devices. You will build prototypes, run tests, and help bring products from concept to launch.

Reporting to the Director of Instruments Engineering, you will collaborate with R&D, engineering and manufacturing teams, maintain equipment, perform IQ/OQ/PQ validation, and ensure compliance with ISO 13485 and FDA 21 CFR Part 820.