Technical Documentation Specialist

at  Endomag

Job title: Technical Documentation Specialist
Contract: Full-time permanent role.
Location: 330 Cambridge Science Park, Milton Road, Cambridge, CB4 0WN
Working model: Hybrid
Responsible to: Systems Engineering Director
Key working relationships: Product Development Engineers, Product Engineers, Development Program Manager, Clinical Director, Clinical Development Manager, Regulatory Affairs Specialists, QA/RA Compliance Manager, QA Officers

QUALIFICATION

• Bachelor’s or master’s degree in engineering or a scientific field

EXPERIENCE AND KNOWLEDGE

• Proven experience in creating and editing technical reports and documentation.
• Exceptional attention to detail and high levels of accuracy.
• Ability to work independently and collaborate effectively within a cross-functional team.
• Demonstrated ability to take ownership of initiatives, deliver results, and drive continuous improvement.
• Excellent content creation and editing skills.
• Strong written and verbal communication skills, with the ability to communicate effectively with cross-functional teams and regulatory agencies.
• Good organizational and time management skills to handle conflicting priorities and meet tight deadlines.

DESIRABLE EXPERIENCE ALSO INCLUDES:

• Multidisciplinary engineering experience (e.g., software, electro-mechanical, or production engineering).
• Knowledge of FDA and MDR regulations, and international standards such as ISO 13485, ISO 14971, ISO 60601, ISO 62304, and ISO 10993.
• Experience in design assurance, quality or technical documentation roles in the medical device industry or other regulated industries, e.g. automotive, aerospace.

THE PURPOSE OF THE ROLE:

As a Technical Documentation Specialist at Endomag, you will play a pivotal role in ensuring the accuracy, consistency, and compliance of technical documentation for our products. You will collaborate with multi-disciplinary engineers, clinical trial managers, regulatory affairs specialists, and quality assurance experts to create and maintain audit-ready documentation. Your efforts will directly support Endomag’s mission to deliver innovative, high-quality medical technologies that transform cancer care and improve patient outcomes worldwide.

KEY RESPONSIBILITIES AND DUTIES:

• Manage the Technical Documentation: Oversee the creation and maintenance of technical documentation for Endomag’s products, including user needs, design inputs, design outputs, verification and validation testing plans and reports, engineering drawings, and manufacturing specifications.
• Lead Cross-Functional Collaboration: Act as the primary liaison between R&D, Regulatory Affairs, Clinical Affairs, Product Engineering, and Quality Assurance, ensuring seamless integration of their inputs into the technical documentation.
• Champion Good Documentation Practices: Adopt a meticulous approach to creating and editing content, driving efforts to improve documentation practices and ensure consistency and audit readiness.
• Support Regulatory Compliance: Review and update engineering reports, design specifications, verification and validation tests, and other technical documents to ensure compliance with Endomag’s Quality Management System, FDA, MDR regulations, and applicable international standards (e.g., ISO 13485, ISO 14971).
• Participate in Regulatory Submissions and Audits: Facilitate reviews by internal and external auditors, interact with regulatory agencies as needed, and lead efforts to implement Corrective and Preventive Actions (CAPAs).