This role ensures compliance with critical medical device regulations including ISO 13485, IEC 62304, and ISO 14971 while partnering with engineering teams to align processes
Job Summary
This role ensures compliance with critical medical device regulations including ISO 13485, IEC 62304, and ISO 14971 while partnering with engineering teams to align processes.
The engineer will develop and execute comprehensive test plans and validation documentation to verify software meets requirements through functional, regression, and user acceptance testing.
BD offers a supportive environment where associates are encouraged to learn, grow, and bring their authentic selves to work in a fast-paced healthcare industry.
Matching Summary
This role ensures compliance with critical medical device regulations including ISO 13485, IEC 62304, and ISO 14971 while partnering with engineering teams to align processes.
Salary
Base: $102,000.00 - $168,200.00 USD Annual; Bonus/Equity: Not specified; Benefits: Competitive package including well-being and development rewards
Skills & Requirements
Must-have
ISO 13485 Quality Management Systems
IEC 62304 Software Lifecycle Processes
ISO 14971 Risk Management Application
Secure SDLC and Quality Expectations
Functional Regression Integration Testing
Vulnerability Remediation and Secure Coding
Nice-to-have
Cross-functional collaboration skills
Process improvement mindset
Root-cause analysis expertise
Risk-based decision making
Continuous improvement culture
Key Requirements
Bachelor's Degree in Computer Science, Risk Management, or Quality Assurance
3-5 years of relevant professional experience
Minimum 4 days per week in-office presence required