Usability Documentation Specialist

5 months ago


Wokingham, United Kingdom Intersurgical Full time

Job Advert

An exciting opportunity has arisen for a Usability Documentation Specialist** **to join our thriving UK Medical Device Manufacturing Company.

We are looking to recruit a Usability Documentation Specialist** **who will be responsible for supporting product development by creating and managing the usability documentation for development projects and for regulatory submissions. For the position, you will be required to take ownership of generating all relevant usability documentation for complete usability engineering files, ensuring compliance to the usability standard.

**Essential Experience/Qualifications**
- A university degree, or equivalent qualification, relevant to science, engineering or human factors / usability
- Knowledge and understanding of the usability standard BS EN 62366-1
- Experience in creating and managing usability documentation for development projects and regulatory submissions

**Desirable Experience/Qualifications**
- Experience in usability and human factors engineering, particularly in medical device development
- Experience in risk analysis and hazard assessment activities for the user interface
- Knowledge of medical device regulations (UKCA, MDR, FDA, etc.)

**Key Skills**
- Strong documentation skills
- Excellent attention to detail
- Able to gather, evaluate, critically interpret and communicate information
- Strong analytical and problem solving skills
- Excellent verbal and written communication skills
- Able to build good working relationships
- Able to work well under pressure and meet deadlines
- Able to multitask and prioritise workload
- Able to make decisions
- Able to work independently as well as within a team
- Able to work effectively across a number of interrelated departments
- Self-motivated
- Have a can-do attitude with an enthusiastic approach to work
- I.T. Literate - Microsoft Office
- Methodical, organised and structured approach to work
- Able to function in a highly regulatory environment with a focus on compliance
- High level of commitment
- Flexibility to work additional hours if required to support the business needs

**Hours of Work**
- 40 hours per week

**No Agencies please



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