Senior Medical Device Systems Engineer (Imaging)

RXinsider LTD.; Goleta (CA); Hybrid; USD 150,000 - 185,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc.

is seeking a Staff Systems Engineer to shape next-gen medical products and support existing ones, with expertise in complex electro-mechanical systems and surgical devices. You will perform requirements analysis, create DFMEA, risk analysis, and ensure traceability across RMF, IO/ V&V, and regulatory submissions to MDR and FDA; collaboration with regulatory, product management, and engineering teams is essential.

Qualifications

• Minimum 8 years of related engineering experience with a Bachelor's degree; or 6 years with a Master’s; or 4+ years with a PhD.
• Experience in medical imaging and medical device development preferred.
• Experience with 60601-1 / EMC testing preferred.
• Strong systems engineering, risk analysis, and documentation skills.

Responsibilities

• Lead the system architectural development of next generation 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. Participate in developing the voice of customer, including attending conferences, operating rooms and labs, and analysis of competitors product offerings and system configurations
• 60601-1 subject matter expert for technical peer reviews

Skills

System architecture

Requirements engineering

Verification & validation

Risk analysis

Regulatory compliance

Cross-functional collaboration

Technical leadership

Education

Bachelor's degree in engineering

Master's degree in engineering

PhD

Tools

IOVV matrix

RMF management

EMC testing

60601-1 knowledge

Job description

B. Braun Medical Inc.

is seeking a Staff Systems Engineer to shape next-gen medical products and support existing ones, with expertise in complex electro-mechanical systems and surgical devices. You will perform requirements analysis, create DFMEA, risk analysis, and ensure traceability across RMF, IO/ V&V, and regulatory submissions to MDR and FDA; collaboration with regulatory, product management, and engineering teams is essential.