About Occuity

At Occuity, we are pioneering ground-breaking technological solutions to alleviate some of humanity’s greatest healthcare challenges by developing technology that takes instant health diagnostic information simply by looking in the eye. With our clear vision and values, a world-leading team of experts, 9 international patents and more pending, we are developing a hugely innovative range of products that will improve the lives of millions of people around the world. Healthcare challenges are there to be solved and at Occuity, we have the vision and the technical ability to succeed. Occuity’s aim is for our accessible, non-contact, mobile diagnostic health devices to make repetitive, invasive monitoring a thing of the past.

At Occuity, we value being at the forefront of cutting-edge technology and we have an incredible team of people helping us do just that. Our employees are excited to be part of a team that thrives in a culture of innovation and imagination. Our success means that we are now expanding at a rapid pace and we are seeking truly exceptional people to join our team. We are looking for trailblazers, visionaries and the naturally inquisitive; those who can challenge and those who can inspire. At Occuity, every single person has a voice - and a vital contribution to make to our success.

If this sounds like you, why not join us on our journey?

The Role

This is a fantastic opportunity for an enthusiastic individual who is looking for a hybrid role between R&D and Quality. The role will encompass involvement in early stage R&D projects, in addition to aiding the management of products already launched onto the market. Primarily, as R&D Quality Engineer, this role will involve the generation and review of documentation required for risk management. However, this role will require cross-functional working to help solve a variety of design issues, lead quality activities and progress the development of Occuity’s novel ophthalmic devices.

With an ambitious vision to improve the lives of millions of people around the word, Occuity has the potential to deliver true innovation. You will play an important role in our future success. The work will be fast-paced and exciting, with exposure to MDR, MDD and 21CFR820.

Key Duties and Responsibilities

• Support design & development of novel medical devices and quality activities undertaken as per the requirements of ISO 13485, EU MDR 2017/745 & 21CFR820
• Provide input into verification & validation activities undertaken to support the development of R&D prototypes
• Support and facilitate effective risk management activities both internally and externally with manufacturing facilities
• Generation, approval and retention of Occuity devices risk management documentation, ensuring that all quality and regulatory requirements are satisfied
• Support design for devices, and manufacturing investigations used in clinical trials and commercial manufacture
• Review and approve validation protocols including IQ, OQ and PQ, providing support for any statistical techniques and analysis required
• Support internal and external audits
• Provide regulatory and quality education and training where appropriate
• Support the assessment of external suppliers for capability of quality systems, facilities and procedures to support both device development and supply
• Review and approve project-related documentation to ensure compliance with regulatory requirements
• Support the generation of regulatory submission data and content for assigned device projects

Experience, Skills and Qualifications

Essential

• Previous experience within a Quality Engineering, Quality Assurance or Regulatory role in a class II medical devices environment is essential
• Demonstrable knowledge of the following regulations in order to act as the subject matter expert within the development team: ISO 13485; ISO 14971; 21 CFR 820; EN 60601; EN 62304; EU Medical Devices Directive and EU Medical Devices Regulation
• Experience in developing documentation used as components of design history files, risk management files and other appropriate regulatory submissions
• Candidates must demonstrate a clear sense of urgency in making things happen, in addition to exhibiting exemplary attention to detail
• Demonstrable experience of collaborative team working both internally with multi-disciplinary teams, and externally
• Proven experience in coding software (e.g. MATLAB, C++, Arduino)
• Experience with 3D CAD tools

• Experience of working in a lab-based environment
• Candidates must be self-starters, with proven problem-solving capabilities
• First-class people skills

Personal Attributes

• Enthusiastic and passionate
• Self-motivated, persistent and collaborative, you have a “can-do” attitude and approach
• A keen eye for detail
• Tenacious and persistent with a determination to go the extra mile to see all projects through to completion
• Equally capable of working independently or as part of a team
• An excellent communicator, you are adept at information sharing and contributing towards an open, positive team atmosphere
• You are excited about the prospect of making a real difference to people’s health around the world

Equality & Diversity

Occuity is committed to encouraging equality, diversity and inclusion among our workforce, and eliminating unlawful discrimination. The aim is for our workforce to be truly representative of all sections of society and our customers, and for each employee to feel respected and able to give their best.

Further details on our Equality, Diversity and Inclusion policy can be found online.