Description

You will manage system design and risk management within a Software as a Medical Device (SaMD) context.

Responsibilities

• Execute requirements engineering and risk management per ISO 14971.
• Design systems and interfaces while evaluating technical design alternatives with development teams.
• Manage requirements development, user stories, and backlogs in collaboration with Product Management.
• Define non-functional requirements including scalability, performance, supportability, and reliability.
• Plan verification and validation testing strategies and conduct test protocols.

Required Skills

• 4+ years of experience in a professional Engineering role.
• Degree in Engineering, Science, Information Systems, or equivalent.
• Sound understanding of the product development life cycle within a QMS.
• Experience with risk management and interface design.
• Ability to manage requirements for UX, Regulatory, Clinical, and Marketing needs.
• Knowledge of information security management systems and data confidentiality protocols.

Preferred Skills

• Experience with SaMDs, web development, and cloud computing platforms like AWS.
• Knowledge of ISO 13485, 21 CFR Part 820, and QMS implementation.
• Experience with Scrum agile methodologies and SaMD cyber-security guidance.

Key Skills

Education

Any graduate