Leuven, Flemish Region, Belgium
Global Project Manager & System lead with strong technical leadership in all phases of regulated (ISO13485) NPD projects: ► Expertise in early-stage technology demonstration up to proof of concept, system requirements, design control, V&V, suppliers selection & management, manufacturing process dev. and validation, up to product launch ► 15y in Diagnostics Point Of Care and microfluidic industry, ► 6y in Biotech industry (single use, hardware, automation), ► Lead global, complex & cross-functional NPD projects to completion (>$1M capex/opex), ► Apply Lean principles and develop solutions through research and solid technical principles, ► Easily switch from helicopter to detailed view, strong analytical and troubleshooting skills, ► Thrive in fast-paced, multidisciplinary, dynamic environment, ► Experience leading conversations, team workshops to consensus and actions, ► Lead diverse, cross-disciplinary, multicultural functional teams in a matrix organization, ► Build lasting relationships at all levels (inside and outside organization), ► Strong people focus with willingness, capability and interest to develop teams to drive excellence, ► Strong entrepreneurship mindset.
From pioneering research to innovative vaccines and therapies, our customers are transforming medicine and saving lives. Now, Cytiva and Pall Life Sciences are joining forces to best support this vital work.
Pall Life Sciences provides cutting-edge products to meet the demanding needs of customers discovering, developing and producing life-changing therapies (biotech drugs, vaccines, gene therapies...). The iCELLis bioreactor is the world’s first fully integrated high-cell density bioreactor designed to simplify cell production processes. - Manage iCELLis single-use bioreactor improvement program: bringing together several sustaining and improvements projects, 15+ core team members across various functional teams (R&D, PE, Supply Chain, Production, QARA, Product Mgmt, Marketing) - Lead system integration, verification and validation - Coordinate risk management - Grow team, resolve resource conflicts, generate technical solutions with the team > Successful market launch of 1st wave of improvements (Apr2020) despite pandemic. > Successful market launch of 2nd wave of improvements (Apr2021) despite pandemic.
miDx aims at developing diagnostic tests integrated in silicon chips by combining the know-how and technical expertise of researchers at imec and The Johns Hopkins University. This collaborative life science venture is developing single-use diagnostic devices to enable faster and more efficient healthcare at any point of need. - Lead hardware development of the Silicon nanofluidic system, - Develop internal technology roadmap and system development milestones, - Lead and coach internal hardware engineering team, coordinate efforts among other technical teams, - Coordinate manufacturing and testing activities around the microfluidic disposable and optical reader, - Manage suppliers relationships (microfluidic disposable, reader, electronics, Si chip manufacturer), - Evaluate performance through experimental testing and alignment of results with all development teams, - Create user requirement and review technical feasibility with suppliers to generate specifications, - Generate project framework for imec’s chip team to create focus on most critical technical challenges (work packages, priorities, deliverables and resources),
The Minicare system aims at delivering lab-equivalent test results at point-of-care within minutes. The Magnotech technology is based on the use of magnetic nano particles to concentrate, separate and detect target molecules. This new type of biosensor technology enables blood testing in a more patient friendly way providing results in a matter of minutes at the point-of-care. - Lead technical development and design control of the Minicare microfluidic-based disposable following Philips QMS: optical/fluidics/mechanical specifications, drawings control, design performance evaluation, design change, sub-system and system-level FMEA, design verification, manufacturing process validation and transfer to manufacturing, responsible for DHF, - Lead project activities around the microfluidic disposable development: create development plan, set project timelines, lead internal review meetings with parallel development teams and integral project management, - Key technical interface with suppliers: identify and implement improvements in QMS/QCs/SOPs, coordinate root cause analysis, implement and report changes, organize trainings, - Oversee formal validation of production tools and injection molding process at suppliers site, - Lead introduction of new microfluidic disposable designs for next-generation product: lead brainstorm sessions with stakeholders, convert ideas into concepts, specification definition, - Responsible for the microfluidic disposable life cycle management: resolve issues related to fabrication or assembly and implement necessary changes, identify cost reduction opportunities.
qSTAR Medical aims to improve the lives of patients suffering from End Stage Renal Disease (ESRD) by developing an innovative vascular access device featuring STAR® Biomaterial. - Lead the design, testing and manufacture of the “next-generation” vascular access implant device, - Manage Product Design Control through outsourced design and manufacturing partner, - Conduct design reviews with project team based in Seattle (WA, USA).