LinkedIn Facebook
About Us

Product Design Owner (H/F)

Product Design Owner (H/F) Product Design Owner (H/F) Product Design Owner (H/F)
18/01/2022 Innovation

Product Design Owner (H/F)

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 lay the foundation stone of their future headquarters. This collaborative environment will allow a positive synergy between R&D activities, production, logistics and administration. Our technological platform will be in the Science Park of Liège and will be up and running from 2022.

To support its development, EyeD Pharma is hiring a Product Design Owner.

Your responsibilities

The product design owner (PDO) is at the center of the product design and development cycle.

  • Accountable for the translation of user’s needs into product requirements.
  • Provide technical expertise in the areas of design inputs definition, verification & validation strategy and ensures the product design outputs meet the design inputs.
  • Ensure the safety, low risk profile, reliability, ergonomics, and quality of the product being developed.
  • Responsible to develop and maintain product knowledge and documentation for a given product family during product development and life-cycle management.
  • Creation, ownership, and maintenance of DHF documents related to Product (Drug & Device) Design Development according to ICHQ8 / ISO13485.
  • Lead definition of product specifications and critical quality attributes.
  • Lead product risk management and own risk management files.
  • Lead and manage usability and human factor studies.
  • Act as SME for pharmaceutical and medical device development activities subcontracted to third parties (provide inputs, activities oversight and planning, review & approval of protocols/reports, follow-up of requests).
  • Contribute to the writing and review of CMC or technical documentation sections for regulatory filing.
  • Lead product life-cycle management (product improvement, change control, post-market surveillance).
  • 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, with at least at least 5 years
  • Minimum of 3-5 years of relevant experience in R&D department of the pharmaceutical or medical device industry.
  • Strong knowledge of the requirements of medicinal product, medical device, and/or combined product design & development (ICH Q8, ISO13485, GxPs).
  • Good command in quality risk management (ICH Q9, ISO14971, IEC62366).
  • Experience in drug delivery system based on polymer technology is a plus.
  • 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.
  • Goal-oriented.
  • Fast learner.
  • Team player, Integrity, Caring
  • Proactive and willing to work in a start-up environment.

EyeD Pharma offers 

  • A permanent position in an innovative and dynamic and fast growing company;
  • Full time ;
  • Liège.

   
Please send your CV and cover letter in English to : job@eyedpharma.com.

 

Our values

Patient Driven

All our product candidates aim to enhance patient quality of life and are based on clinical unmet need identified by internationally renowned KOL’s

Patient Driven
Breakthrough Innovation

We manage all the expertise and processes, from the idea to the market

Breakthrough Innovation
Corporate Responsibility

Creation of high-quality long-term employment and significant contribution to the economic redeployment of Wallonia. Eyed’s team is today composed of 66 FTEs

Corporate Responsibility
Humanitarian Mission

Our technological platform allows to give access to long term innovative ophthalmological treatments to developing countries populations, where glaucoma is the second cause of blindness

Humanitarian Mission