Periode: 1 year
Our client is a leading Project Management and Engineering Company serving industry around the world. Their reputation is based on forming successful partnerships with their clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence.
They provide Full Service Engineering for their clients including Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up on numerous projects across a range of market sectors.
As part of the implementation a need has been identified within the life cycle management activities required to comply with EU-MDR. Life Cycle Management is a description for all activities after a product has been commercialized, meaning any changes that are required based on customer feedback, changes needed based on input from regulatory bodies or any corrective actions.
Therefor our client is recruiting a hands-on Staff Product Management Engineer that will integrate internal and external EU MDR teams, reporting to the EU MDR site lead.
Key Responsibilities include but are not limited to:
- Lead the Lifecycle Product Process to comply with EU-MDR which includes leading a cross-functional team to review the projects' business case, conduct risk analysis and develop recommendations for approval, priority and project change governance;
- ensure stakeholders understand outputs of all decisions and track project status;
- planning phase in/phase out of changes requiring commercial strategies and/or communications and accountable for execution;
- lead and conduct proactive risk analysis and mitigation strategies for continuity of quality supply;
- is part of site EU-MDR teams;
- single point of contact of the project for the team, site lead and the stakeholders;
- assure the process changes throughout the year required to comply with EU MDR are integrated accordantly.
- A minimum of a bachelor’s degree in Engineering is required. Master's degree in Engineering is preferred;
- a minimum of 5 years’ experience in Engineering within New Product Development, Quality, and/or Manufacturing with significant technical project and leadership accountabilities is required;
- must have demonstrated successful completion of developing and leading several technical and/or business challenges;
- demonstrated ability to lead a cross-functional team is required;
- demonstrated understanding of the healthcare regulated industry Quality Systems and Change Control procedures is required;
- must have experience in the medical device or pharmaceutical industry;
- Six Sigma / Process Excellence and/or Design Excellence experience is preferred;
- must have advanced proficiency with written and verbal communications (Dutch and English);
- proficiency with MS Office and Statistical Analysis Software is required (Word®, Excel®, PowerPoint®, Minitab®, Visio®, Microsoft Project).