Medical Device R&D Technician - Prototyping & Validation

Route 92 Medical; San Mateo (CA); On-site; USD 48,000 - 59,000; Full time

Benefits offered by this job

Healthcare benefits from day one

Paid time off

Parental leave (12 weeks)

Cell phone stipend

Equity opportunity

Job summary

Route 92 Medical is seeking a hands-on technician to support engineering by building prototypes, performing validation builds, and transferring products to production in our San Mateo, CA office. The role involves extensive time in a clean room and collaboration with QA and manufacturing teams.

The ideal candidate has 3+ years in the medical device industry, familiarity with catheter manufacturing, and the ability to read engineering drawings.

Qualifications

• High School diploma or equivalent required.
• Experience with product testing using Instron is a plus.
• Ability to understand engineering assembly drawings preferred.

Responsibilities

• Function in a clean room environment for approximately 75% of the time.
• Collaborate with technicians to create prototypes and processes for new products or revisions with a zero-defect mindset.
• Assist in manufacturing of devices for verification, validation, and human use builds per GMP.
• Establish manufacturing processes for new products and train operators (in-house and at contract manufacturers).
• Learn and perform product testing and maintain test datasheets.
• Adapt to shifting tasks in a fast-paced product development program.
• Troubleshoot basic manufacturing issues with minimal oversight.
• Update supervisor on progress and improvement recommendations.
• Maintain thorough records of materials, parts, drawings and processes.
• Provide feedback on revisions to project engineers and other personnel.
• Train assemblers during transfer of products.
• Maintain clean, safe and organized work area.
• Coordinate with QA and Manufacturing on assignments and feedback.
• Support company policies, QSR and FDA regulations.

Skills

Instron testing

Engineering drawings

Education

AA in a technical field

High School diploma or equivalent

Job description

Route 92 Medical is seeking a hands-on technician to support engineering by building prototypes, performing validation builds, and transferring products to production in our San Mateo, CA office. The role involves extensive time in a clean room and collaboration with QA and manufacturing teams.

The ideal candidate has 3+ years in the medical device industry, familiarity with catheter manufacturing, and the ability to read engineering drawings.