Medical Device Test Technician — ISO-13485 QC & Data

Medium; Golden (CO); On-site; USD 34,440 - 37,195; Full time

Benefits offered by this job

Medical/Dental/Vision/Life

Disability - STD & LTD

401(k) matching

11 Company Holidays

Vacation time

Home Office Benefits Stipend

Job summary

BioIntelliSense is seeking an Operations Technician to join our warehouse team in Golden, CO. You will test electronic devices, create test procedures, inspect products, and maintain a clean, safe testing area while troubleshooting equipment and suggesting improvements.

Responsibilities include GDP compliance, ISO 13485 support, running computer-driven test setups, recording data accurately, and collaborating with engineers to solve technical problems. Prior FDA/ISO13485 experience preferred.

Qualifications

• Strong communication, writing and presentation skills; ability to read and write in English.
• Knowledge and use of relevant computer software applications.
• Sound understanding of electronics technology.
• Extensive experience running computer driven test set-ups.

Responsibilities

• Complete daily tasks in accordance with BioIntelliSense Policies and Procedures, including safety rules and regulations.
• Must follow Good Documentation Practices (GDP).
• Prioritize work orders for Service and Fulfillment and ensure timely completion with no failures.
• Work with engineers to build and test solutions to technical problems.
• Inspect and modify existing designs and prototypes.
• Conduct tests, collect data, and record clearly and accurately.
• Analyze operations and offer improvement suggestions.
• Maintain accurate records and assist with data collection for metrics and presentations.
• Set up computer driven test equipment and supporting processes.
• Create procedures to document the test process.
• Conduct inspection of devices.
• Run diagnostics and calibrations.
• Inspect inventory and re-order materials and components.
• Support ISO 13485 standards.
• Perform 5S daily.
• Identify and report non-conforming material and product.
• Apply product traceability.
• Perform packaging and labeling duties.
• Train and transfer knowledge to team members.
• Lead and positively influence others in a team-based environment.

Skills

Strong communication

English proficiency

Electronics knowledge

Computer software proficiency

Test equipment operation

Tools

Computer driven test setups

Job description

BioIntelliSense is seeking an Operations Technician to join our warehouse team in Golden, CO. You will test electronic devices, create test procedures, inspect products, and maintain a clean, safe testing area while troubleshooting equipment and suggesting improvements.

Responsibilities include GDP compliance, ISO 13485 support, running computer-driven test setups, recording data accurately, and collaborating with engineers to solve technical problems. Prior FDA/ISO13485 experience preferred.