Staff Systems Engineer - Medical Device & Imaging Leader

Velocity Resource Group; Goleta (CA); Sur place; USD 150 000 - 185 000; Plein temps

Résumé du poste

The Staff Systems Engineer at B. Braun Medical Inc. will shape future medical devices through system architecture and rigorous verification/validation.

You’ll author design documents such as DFMEA and risk analyses, and collaborate across regulatory, clinical, and product teams to ensure MDR/FDA compliance. Ideal candidates bring 8+ years in engineering (or PhD with 4+ years), strong imaging/optics experience, and a proven track record in 60601-1 testing and cross-functional risk management.

Qualifications

• Typically requires a minimum of 8 years of related engineering experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 4+ years experience; or equivalent experience.
• Expertise in medical imaging and scientific imaging technologies preferred.
• Experience with optical concepts, optical design and camera technology nice to have.
• Experience with measurement automation nice to have.
• Experience shepherding product through 60601-1 / EMC testing preferred.

Responsabilités

• Lead the system architectural development of next generation highly technical medical products, including electrical, optical, mechanical, industrial design, and software development.
• Create system level documentation to organize architectures, create strategies, and mitigate risk.
• Develop system level requirements and verification/validation tests to cover all aspects of system performance.
• Work with project management to create schedule and cost estimates for project execution.
• Work jointly with regulatory affairs to prepare test results and submission to regulatory organization worldwide, including compliance with MDR and FDA.
• Maintain the traceability between system requirements and verification testing via Inputs Outputs Verification Validation (IOVV) matrix
• Own and maintain the system Risk Management File (RMF) via cross functional risk analysis, including essential performance
• Conduct technical proof of concepts of emerging medical technologies, to develop and refine the next generation of products.
• Work closely with product management to understand/translate voice of customer.
• 60601-1 subject matter expert for technical peer reviews

Connaissances

System architecture

Regulatory knowledge

Risk management

Verification & validation

IOvv matrix

Medical imaging

Formation

Bachelor’s degree in engineering

Master’s degree

PhD (optional)

Outils

Optical design

Camera technology

Measurement automation

Description du poste

The Staff Systems Engineer at B. Braun Medical Inc. will shape future medical devices through system architecture and rigorous verification/validation.

You’ll author design documents such as DFMEA and risk analyses, and collaborate across regulatory, clinical, and product teams to ensure MDR/FDA compliance. Ideal candidates bring 8+ years in engineering (or PhD with 4+ years), strong imaging/optics experience, and a proven track record in 60601-1 testing and cross-functional risk management.