Medical Device Verification & Validation Technician

EMED Technologies Corporation; Cameron Park (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

EMED Technologies Corporation seeks a V&V Engineering Technician to support new product development and legacy device validation testing to characterize performance and compile data for global regulatory submissions. The role reports to the Director of R&D and Engineering.

You will perform verification and validation testing of infusion medical devices, generate validation protocols, data analyses, and create technical documentation while helping with regulatory submissions and CAPA

Qualifications

• Bachelor of Science in Engineering or related technical field preferred.
• Minimum 2 years of medical devices testing experience; other non-medical devices experience acceptable.
• Ability to read and understand test protocols and reports using scientific methods and applicable medical device regulations.
• Ability to read and interpret drawings and schematics.
• Experience with Microsoft Office (MS Excel, Word, Outlook and PowerPoint).

Responsibilities

• Perform verification and validation testing of infusion medical devices to support regulatory submissions, design enhancements, and product launches.
• Generate validation protocols, testing, data analysis and reporting.
• Generate and update technical documentation.
• Develop and optimize test protocols that align with EMED’s QMS.
• Coordinate development of prototypes.
• Author summaries and reports from observations and test results for device design enhancements and future protocols.
• Participate in investigations and CAPA related to nonconforming material and audit observations.
• Assist with preparation of documents for regulatory submissions.
• Assist with calibration activities of test equipment.
• Maintain communications with design teams and clinicians/patients as needed.
• Assist with manufacturing process validation.

Skills

Medical devices testing

QA/RA understanding

Troubleshooting

Planning and coordination

Reading drawings

Data analysis

Communication

Education

Bachelor of Science in Engineering or related technical field

Tools

MS Excel

MS Word

MS Outlook

PowerPoint

Job description

EMED Technologies Corporation seeks a V&V Engineering Technician to support new product development and legacy device validation testing to characterize performance and compile data for global regulatory submissions. The role reports to the Director of R&D and Engineering.

You will perform verification and validation testing of infusion medical devices, generate validation protocols, data analyses, and create technical documentation while helping with regulatory submissions and CAPA