Founded in 2012, EyeD Pharma is a pharmaceutical company dedicated to the development of innovative drug products in ophthalmology. EyeD Pharma is developing innovative products based on a new delivery pathway of well-known drugs with the aim of improving quality of life of patients in various ocular pathologies.
In 2019, UniD Manufacturing was born, which brings together production activities.In parallel with its R&D and industrialization activities, EyeD Pharma started in 2017 a commercial activity of medical devices (equipment and consumables) for eye surgery. EyeD Pharma and UniD Manufacturing are both located in the Science Park of Liège, allowing a positive synergy between R&D activities, production, logistics and administration.
To support its development, EyeD Pharma is hiring a Usability Engineer.
The Usability Engineer has a key role in translating customer/user requirement into products that are safe and effective for the user.
- Subject Matter Expert for Usability Engineering/Human Factor in medical device and combination products.
- Provide expertise in Usability Engineering activities including integration of known and foreseeable use, preliminary Usability Engineering analysis, task analysis, use-related risk analysis, and creation and maintenance of Usability Engineering files.
- Lead cross-functional team to ensure appropriate input are collected, context of use is clearly defined, insights properly translated into user needs, use-related risk analysis guides usability testing strategy, studies are designed fit-for-purpose based upon objectives, scope, and phase of project.
- Drive appropriate usability engineering activities to improve the design of products, specifically the user interfaces, including the product, packaging, labeling, and instructions for use while minimizing the potential user errors.
- Work directly with users to develop and evaluate new product features, user interfaces and ergonomic designs elevating the overall user experience.
- Lead study design, protocol development, and execution of formative and summative evaluation.
- Create, own, and maintain DHF documents related to Product (Drug & Device) Design Development including usability plan, use specification, use-related risk analysis, usability validation report for inclusion in regulatory filing.
- Contribute to the safety, low risk profile, reliability, ergonomics, and quality of the product being developed.
As part of EyeD Pharma product design office, the Usability Engineer will also:
- Contribute to the translation of user’s needs into product requirements.
- Contribute to the definition of product specifications and critical quality attributes.
- Contribute to overall product risk management.
- Provide technical expertise in the areas of design inputs definition, verification & validation strategy and ensures the product design outputs meet the design inputs.
- Contribute to the preparation of documentation to support development activities for inclusion in regulatory filing.
- Contribute to the establishment of effective project schedules and milestones, identify project risks and propose mitigation plans. Escalate if appropriate.
- Ensure critical data review and compliance with GxP and standards requirements for all operations.
Your profile :
- Master's degree in a scientific discipline preferably in chemical or biomedical engineering, pharmaceutical sciences, or polymer chemistry
- Minimum of 1-3 years of relevant experience in R&D department of the pharmaceutical or medical device industry.
- Very good command in quality risk management (ICH Q9, ISO14971) and in Usability Engineering (IEC62366, FDA’s Human Factors Guidance).
- Strong knowledge of the requirements of medicinal product, medical device, and/or combined product design & development (ICH Q8, ISO13485, GxPs).
- Experience in ophthalmology is an asset.
- Strategic thinking, strong problem-solving and analytical skills.
- Strong written and verbal communication skills.
- Fluent in English and French.
- Open’ thinking and flexibility.
- Self-motivated and autonomous.
- Fast learner.
- Team player, Integrity, Caring
- Proactive and willing to work in a start-up environment.
EyeD Pharma offer
- A permanent position in an innovative and dynamic and fast growing company;
- Full time ;
Please send your CV and cover letter in English to : firstname.lastname@example.org.