Product Management Engineer

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Medical Devices organisation, based in Zuid-Holland Netherlands.

The Company

The company is a multinational manufacturer of medical devices.

Role Description

The Product Management Engineer will be responsible for the integration of the internal and external teams who are tasked with the implementation of the new European Medical Device Regulation (EU-MDR) to the company. 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.

Responsibilities

- 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 company's 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

Requirements

- at least a Bachelor degree with 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.
- Proficiency with MS Office and Statistical Analysis Software is required (Word®, Excel®, PowerPoint®, Minitab®, Visio®, Microsoft Project).

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Alexander Wielemaker.