Senior Software Engineer

What You Will Do

Primary Responsibilities

• Assist in the facilitation of internal and third-party audits as needed.
• Interpret industry standards and government regulations to drive the implementation of world-class processes, providing resources and removing obstacles to team accomplishments.
• Leverage Design Controls expertise for product development projects from inception through successful design.
• Possess a foundational understanding of product security and Risk Management strategies.
• Recommend efficiency and process improvements for product security capabilities and functions.
• Collaborate with product teams to assess security risks.
• Clearly convey design control and Product Security-related issues to stakeholders.
• Create gap assessments between different processes and ensure their fulfillment.
• Communicate security gaps to leadership and propose mitigation solutions.

What You Need

Knowledge/Competence

• 3-7 years of experience.
• Basic expertise in applying security control frameworks, security risk assessments, and scoring the severity of security threats and vulnerabilities.
• Effective verbal and written communication and consensus-building skills.
• Demonstrated technical problem-solving skills.
• Strong understanding of Quality Management Systems (QMS) and Software Development Life Cycle (SDLC).
• Basic understanding of the vulnerability management life cycle.
• Experience working in a regulated medical organization is essential.

Good to Have

• Familiarity with the ISO 13485 standard.
• Experience in New Product Development for Software and/or Systems is preferred.
• Knowledge of FDA Cybersecurity guidance (including FD&C 524B and eSTAR updates).
• Hands-on experience using Agile methodology.
• Understanding of security risk management processes, preferably in the healthcare or medical device industry.