Medical Device Engineer
Akkodis is an organization with more than 1,000 engineering, scientific and digital experts in Belgium. Our mission is clear: create a smarter future together! We are a one-stop-shop for engineering, IT, Life Science, and new technologies. Our combined passion for talent and technology allows us to look at the world differently.
With our 360° offer we support companies in all sectors in implementing Smart Industry solutions, from the up and reskilling of entire teams to the delivery of complete project. Our added value? We make incredible happen!
What are your responsibilities?
As part of the Devices, Artwork & Packaging (DAP) organization, this position will focus on providing support to the Device program Leads for the design, development, and industrialization of drug delivery systems from the first new product introduction (NPI) to lifecycle management (LCM) and continuous maintenance.
This position will ensure compliance to Medical Devices regulations and GMP compliance of Drug/Devices Combination Products from a quality, safety and efficacy point of view.
Within the Devices, Artwork & Packaging organization, this role is expected to:
* Contribute to technical activities and ensure the appropriate development, industrialization, lifecycle management, and maintenance of drug delivery systems.
* Collaborate with the program team members, internal stakeholders and external partners,
* Ensure project management of these technical activities performed internally or by external partners,
* Ensure compliance with the medical device Quality Management System,
* Ensure that all intellectual property arising in the course of programs is appropriately protected.
The Medical Device Engineer Scope may include the following activities:
* Act as a focused contributor to additional device programs.
* Contribute to the evaluation of new devices and technologies to supplement existing platforms or to propose new programs. Preparation of conceptual design and proposal of new programs, including translation of internal customer requirements into realistic product and program requirements.
* Provide support in preparation and justification of design verification, design validation, process validation, commercial launch planning, and contribution to respective regulatory submissions.
* Contribute to creation and maintenance of the Design History File during the whole life cycle management. The Device Program Lead (DPL) is accountable for device documentation ownership as mentioned in the Deliverables Matrix template (sop-af-106068). The DPL authoring responsibility can be transferred to a Medical Device Engineer.
* Life cycle management and maintenance of device programs:
o Coordination of the technical activities supporting on-market and life cycle management of medical devices.
o Project management of technical medical device activities in relation to market feedback, lifecycle management and maintenance of technical quality and documentation with both internal and external partners.
o Preparation, justification, and strategic planning of life cycle management opportunities including for secondary regulatory submissions and post-market approval obligations.
What is the profile we are looking for?
* Master’s degree
* 3+ years of experience in the pharmaceutical/biologics/device industry. Operational GMP or quality experience would be a distinct advantage.
* Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements.
* Green Belt and/or Project Management certification will be a distinct advantage.
What’s the offer you can’t refuse?
As an AKKODIS Team member, you will be:
* Onboarded in your position via a buddy process
* Supported in your career by your Business Manager
* Actor of your training plan and your personal and professional development
* Benefiting from a permanent contract
* Benefiting from a competitive salary package including several extra-legal benefits
Do you any questions? You can contact me at