Leo Cancer Care: Requirements Engineer Level I-II

Centaur Health Holdings; Crawley; On-site; GBP 45,000 - 65,000; Full time

Job summary

A leading healthcare technology company in the UK is seeking a Requirements Engineer to assist in the development of revolutionary radiotherapy treatment systems. In this role, you will gather and document requirements, manage the requirements database, and represent the requirements department in cross-functional meetings. Strong communication skills and experience in medical device development are essential. Join a team dedicated to transforming cancer treatment and improving patient experiences.

Qualifications

• Experience working in a medical device development lifecycle.
• Ability to produce precise, consistent, and well-written requirements using the EARS format.
• Effective knowledge of regulatory standards associated with medical device development.
• Excellent verbal and written communication skills.
• Strong creative problem-solving abilities.
• Ability to manage requirement reviews.

Responsibilities

• Gather, identify, and document detailed functional and non-functional requirements.
• Decompose high-level information into a detailed set of requirements.
• Create process flows, use cases, and system models.
• Manage the requirements database using CodeBeamer.
• Produce requirement and traceability reports.

Skills

Medical device development lifecycle

EARS (Easy Approach to Requirements Syntax)

Regulatory standards knowledge

Requirement management tools

Verbal and written communication

Creative problem-solving

Project management

Tools

CodeBeamer

DOORS

Jama

Visure

Job description

Position summary

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.

Key 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.

Relevant Knowledge and Skill 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.

About Leo Cancer Care

Leo Cancer Care is helping make changes in Radiation Therapy by shifting to upright patient positioning, imaging, and treatment. We do what we do to find a better way, a better way to treat cancer and create a paradigm shift in radiation therapy to benefit all. We will do this by improving access to and the quality of cancer care globally, making cancer treatment a more human experience for all.

Working in radiotherapy, not only will you be driving change for the greater good, but you'll be working on products that span a large field of different disciplines.

Ways of Working

Leo Cancer Care is dedicated to fostering a diverse and inclusive workplace environment. We embrace and celebrate the unique backgrounds, experiences, and perspectives of all individuals. We believe that diversity enriches our organization and strengthens our ability to innovate and excel. Discrimination or harassment of any kind will not be tolerated. We encourage all qualified candidates to apply and join us in our mission to create a respectful and equitable workplace for all.

Leo Cancer Care is an equal opportunity employer.