Leo Cancer Care: Requirements Engineer- Level I/II

Centaur Health Holdings • Middleton, WI

15d

About The Position

The Requirements Engineer will work within our product development processes to assist in writing user/system/sub-system requirements for our FDA 510(k) cleared, revolutionary radiotherapy treatment systems. They will work with an experienced team of engineers, clinical representatives, and other internal and external stakeholders.

Requirements

• Experience working in a medical device development lifecycle.
• Ability to produce precise, consistent, and well-written requirements using the EARS (Easy Approach to Requirements Syntax) format.
• Effective knowledge of regulatory standards associated with medical device development.
• Experience with requirement management tools such as DOORS, Jama, Visure, or CodeBeamer.
• Excellent verbal and written communication skills to articulate complex requirements clearly and facilitate discussions and negotiations among diverse stakeholders.
• Must have strong creative problem-solving abilities to address challenges and conflicts that arise during the requirements process.
• Ability to take on projects with minimal supervision.
• Must be able to manage requirement reviews by clearly communicating the purpose, audience, and deadlines.

Responsibilities

• Conduct interviews and perform research to gather, identify, and document detailed functional and non-functional requirements.
• Decompose high-level information into a detailed, unambiguous set of requirements.
• Create process flows, use cases, user stories, and system models.
• Manage the requirements database using CodeBeamer.
• Produce requirement and traceability reports used for our FDA 510(k) submissions.
• Provide support for other team members using our requirements management tool.
• Investigate defects and complaints related to requirements.
• Represent the requirements department in cross-functional meetings.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed