Usability Documentation Specialist

Location: Head Office (Wokingham UK)
Job Type: Full time, 40 hours per week
Contract Type: Permanent
Salary: £35,000-£40,000
Benefits: Family feel company • Flexible working hours • Training and progression opportunities • Annual performance and salary review • Competitive annual leave entitlement • Generous Company contribution toward gym membership • Matched pension contributions with length of service • Cycle to Work Scheme

Closing date: 28-03-2024

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.

The successful candidate will be working alongside the Design, Marketing and Regulatory teams to gather relevant information and be involved in risk-related activities for the user interface.

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**

Why Join Intersurgical

You will be joining a company where our people work together to meet our company goals. We have a strong family feel, a friendly working environment and extend a warm welcome to all new employees. We are looking for commitment, a strong work ethic and flexibility in all our people and reward those that demonstrate these qualities. Intersurgical is only as good as the people who work for us, and we value all of our employees.

You may also have experience in the following: Human Factor Engineering, Engineering, Usability Documentation Manager, Medical Device Management, Medical Engineering, New Product Development Executive, Product Development Executive, Product Development, Product Development Assistant, New Product Development, Project Management, Product Management, Usability specialist etc

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