Technical Documentation Specialist - 12 months FTC

Hologic Inc.; Cambridge; Hybrid; GBP 35,000 - 50,000; Full time

Job summary

A leading healthcare technology company in Cambridge is seeking a Technical Documentation Specialist for a 12-month fixed-term contract. In this role, you will ensure the accuracy and compliance of all technical documentation by collaborating with cross-functional teams including engineering and quality assurance. Ideal candidates will have a background in engineering or scientific fields along with experience in the medical device industry. Join a supportive team and make an impact in cancer treatment technology.

Benefits

Collaborative culture

Opportunities for personal growth

Qualifications

• Must have experience in creating and editing technical reports and documentation.
• Experience in design assurance or quality roles in regulated industries is desirable.
• Exceptional attention to detail and ability to meet deadlines are necessary.

Responsibilities

• Oversee creation of technical documentation for products.
• Collaborate with cross-functional teams to integrate inputs into documentation.
• Ensure compliance with regulatory standards and Good Documentation Practices.
• Facilitate regulatory submissions and audits.

Skills

Attention to detail

Content creation and editing

Communication skills

Organizational skills

Technical documentation experience

Education

Educational background in engineering or a scientific field

Job description

Technical Documentation Specialist - 12 months FTC

Cambridge, Cambridgeshire, United Kingdom

Technical Documentation Specialist – 12 months FTC

Role location: Cambridge, UK (hybrid working)

Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by shaping the future of cancer care.

At Endomag, a Hologic company, we’re redefining cancer treatment and empowering clinicians worldwide with innovative medical solutions.

We’re now looking for a Technical Documentation Specialist to join our dynamic team in Cambridge on a 12 months fixed term contract. As a Technical Documentation Specialist, 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 to deliver innovative, high-quality medical technologies that transform cancer care and improve patient outcomes worldwide.

KEY RESPONSIBILITIES

• 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 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)

KNOWLEDGE, SKILLS & EXPERIENCE

• Educational background in engineering or a scientific field
• Experience in creating and editing technical reports and documentation
• Exceptional attention to detail and high levels of accuracy
• Demonstrated ability to take ownership of initiatives, deliver results and drive continuous improvement
• Excellent content creation and editing skills
• Excellent 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
• Experience in design assurance, quality or technical documentation roles in the medical device industry or other regulated industries, e.g. automotive, aerospace is highly desirable

Ready to Make an Impact?

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

Innovate with Purpose: Work at the forefront of life-changing medical technology.

Collaborative Culture: Join a friendly, supportive team where your contributions matter.

Personal Growth: Expand your skills in a fast-growing, global company.