Currently I am looking for a hands-on Staff Product Management Engineer that will intergrate internal and external EU MDR teams, reporting to the EU MDR site lead.
Staff Product Management Engineer
The new European Medical Device Regulation will apply in 2020. 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.
Key Responsibilities include but are not limited to:
- Lead the Lifecycle Product Process at Leiden 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 and CSS EU MDR teams;
- Partner within business unit (Marketing, R&D, Quality) and Supply Chain (Source, Plan, Make, Deliver and Quality Ops) functions into product/process change process.
- 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. Experience in ADAPTIV is an advantage
* Must have experience in the Medical Device or Diagnostics industry.
* Six Sigma / Process Excellence and/or Design Excellence experience is preferred.
* Must have advanced proficiency with written and verbal communications.
* Proficiency with MS Office and Statistical Analysis Software is required (Word, Excel, PowerPoint, Minitab, Visio, Microsoft Project).
Are you the Staff Product Management Engineer I am looking for? Please contact me: n.vanalfen[at]realstaffing.com or by phone: 020 522 1588.