Overview
On Site
Full Time
Skills
Risk Management Framework
RMF
Evaluation
Product Development
Software Security
Agile
Regulatory Compliance
Medical Devices
Quality Assurance
ISO 13485
Cyber Security
SIMD
Cloud Computing
Artificial Intelligence
Machine Learning (ML)
Design Controls
Documentation
Risk Management
Microsoft Office
Microsoft Azure
DevOps
Minitab
Vulnerability Scanning
Six Sigma
ISO 9000
IaaS
Job Details
Responsibilities:
- Partner with development teams to ensure compliance with FDA, ISO 13485, IEC 62304, ISO 14971, and cybersecurity standards.
- Provide quality oversight for Design History Files (DHF), risk management, V&V, and design controls.
- Lead software risk management (RMF), including risk evaluation, control, and mitigation.
- Drive Secure Product Development Framework (SPDF) and software security best practices.
- Support Agile software development teams, ensuring regulatory and quality compliance.
- Own and resolve CAPAs related to design control and software quality processes.
- 8+ years in medical device software quality engineering.
- Deep knowledge of 21 CFR 820, ISO 13485, IEC 62304, IEC 82304, AAMI TIR45, ISO 14971, IEC 60601, and cybersecurity standards.
- Strong experience in SaMD, SiMD, cloud-based software, AI/ML, and security risk management.
- Hands-on experience with design control documentation, risk management, and DHF oversight.
- Proficiency in Microsoft Office, Azure DevOps, statistical tools (e.g., Minitab), and vulnerability scanning.
- Preferred: ASQ CQE, Six Sigma Black Belt/Green Belt, ISO/IEC 27001, cloud infrastructure expertise.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.