Bachelor's degree in computer science or related field
Minimum 2 years experience in regulated environment
Proficiency in risk analysis and software verification
This role involves guiding New Product Development teams to ensure compliance with internal procedures and regulatory standards like FDA and ISO
Job Summary
This role involves guiding New Product Development teams to ensure compliance with internal procedures and regulatory standards like FDA and ISO.
The engineer will partner with cross-functional teams including software, electrical, and mechanical design to deliver secure and effective embedded software.
Responsibilities include managing software builds, leading defect management activities, and performing cybersecurity and safety risk assessments aligned with design controls.
Matching Summary
This role involves guiding New Product Development teams to ensure compliance with internal procedures and regulatory standards like FDA and ISO.
Salary
Base: $89,300 - $148,800 USD Annual; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
Bachelor's degree in Computer Science or related field
Minimum 2 years experience in regulated environment
Proficiency in risk analysis and software verification
Experience with FDA QSRs and ISO 13485 standards
Knowledge of IEC 62304 and ISO 14971 regulations
Nice-to-have
Experience in Medical Device Software (SiMD)
Proficiency in C/C++ Python and Yocto
Cybersecurity certifications like CSSLP or SSCP
Experience with Jira Gitlab and Ansible tooling
Background in threat modeling and security risk analysis
Key Requirements
Bachelor's degree in Computer Science, Engineering, or related discipline
Minimum 2 years relevant experience in regulated environments
Proficiency in risk analysis, architecture, and verification
Knowledge of FDA QSRs, ISO 13485, IEC 62304, and ISO 14971