At a Glance
- Tasks: Lead technical documentation for innovative medical devices and ensure global compliance.
- Company: Paxman, a leader in scalp cooling technology improving lives worldwide.
- Benefits: Competitive salary, benefits, and opportunities for career development.
- Other info: Join a supportive culture focused on innovation and growth.
- Why this job: Make a real difference in patients' lives while leading a talented team.
- Qualifications: Experience in managing technical documentation in regulated environments.
The predicted salary is between 45000 - 55000 £ per year.
Paxman is a global leader in scalp cooling technology, improving the lives of cancer patients worldwide. As they continue to innovate and expand internationally, we're looking for an experienced Technical Engineering Manager to have responsibility for the Technical Files for all Paxman products, ensuring compliance globally.
Areas of responsibility around Technical Files:
- Management of the Design Control Matrix and Risk Management File
- Accountable for the Clinical Evaluation File and Usability File
- Overall sign-off of the Technical File along with other heads of departments
- Leading audits of the technical file
Other areas of responsibility:
- Plan and manage technical CAPAs
- Manage the introduction of engineering changes to product development
- Ensure all devices meet efficacy and safety standards when used during its intended use and possible misuse
- Provide technical specs to suppliers and work closely with suppliers to agree processes
- Ensure labelling and documents are compliant with regulatory legislation
- Supporting new product development and ongoing product lifecycle management
- Support and strategic planning for any new products from a technical perspective
We're looking for someone with:
- Experience at a senior level of managing technical documentation within a regulated manufacturing or medical device environment
- A strong understanding of medical device regulations and quality management systems (ISO 13485/MDR desirable), as is ISO 14971
- Exposure to technical documentation and a regulatory compliance environment
- Experience with design control, risk management and technical file maintenance
- Excellent organisation skills with the ability to manage multiple projects and stakeholders
- Team leadership and mentoring skills
In return you will have the opportunity to:
- Lead a growing technical function
- Mentor and develop your team
- Have significant autonomy
- Gain exposure to a newly launched medical device
- Work in a supportive, people-focused culture
This is a business that:
- Is making a genuine difference to patients across the globe
- Invests heavily in innovation and product development
- Offers the opportunity to work with talented cross-functional teams
- Provides a competitive salary and benefits package with genuine career development opportunities
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