Team manager, 14-18 people, with expertise covering the whole product development life cycle from design through verification, design transfer to validation, Customer Technical support and product life cycle. Represent Cytiva in technical discussions with customers and notified bodies. Support project manager team with planning, resources, budget, cost L&P on R&D activities. Support quality audits by providing engineering and technical support. Bring expertise in FMEAs. Chair technical design reviews and meetings. Accountable in PLM windchill, Magic, Veeva approval workflow. Coordinate and approve the product design verification and validation activities during development phase. including the whole documentation related to FAT, SAT, DOE & characterization, IQ, OQ,PQ, process FMEA, Gage R&R, Cpk, process capability, SPC, GMP Pratices etc. Ensure that customer and own specifications, URS, SRS, sterilization requirements are tracked and fulfilled. Create and spread new Organization of R&D Team. Change from Flat to function oriented Org. Support suppliers strategies “make or buy” for finished goods, kit, single parts, bags and cryo-bags. Coordinate and approve the design transfer activities for NPI/ NPD performed through CMOs and/or done internally. Support design transfer activities when it relates to legacy product engineering activities. Accountable on Overall design, development, V&V and design transfer responsibility of the disposable kits during execution of new product or legacy product engineering projects. Quality Regulatory fulfilment of delivered products. ISO13485 / 9001, FDA 21 CFR, MDD to MDR, CAPA. Work in a matrix organization with cross-functional Research and Development team, in close interaction with the Production, Supply Chain, Quality and Sales & Marketing departments, as well as end-users and suppliers. Foster as Certified Practinioner, Lean Management change to spread DBS (Danaher Business System) tool, (PSP) Problem Solving Process, Kaizen, (VPM) Vitual Project Management, (MPL/PPL) Master & Project Priority List

Create Customer support Dpt. Be the main contact with Customers: Bio-Pharmaceutical manufacturer, Biotech, Fill & Finish, CMO, Researchers. Leverage Quality standards to enhance MDD to MDR transition. Team Management (up to 6p) and Cross-Mgmt. with internal leaders: Regulatory, QA, Experts, Sales, etc. Act as a Project leader in multi sites mode and cross management to reach customer expectations e.g. new line automation for product assembly – automated assembly with internal and external components. Transfer of work on new site and growing capacity. Assembly process including feeding machine, assembly and control steps, Pressure sensors camera. Accountable for documentation URS, FDS, SDS, MDS, FAT, SAT, MDR, TOW, V&V documentation etc. Develop training program to enhance product adoption at CMO, R&D lab, Marketing & user levels. Customer facing close work with Sales and Marketing team. Accountable of Planning and project reporting. Manage Customizations on Primary container Device mainly in Plastic molded. Follow IQ, OQ,PQ with transfer to customer. Main Accountabilities: enhance Customer Support Services, deal with training, complaint, investigation and resolution, maintain up to date by Supporting and training marketing & sales teams, Customers main contact point. Identify cost and profit improvement. Responsible for external activities, suppliers and workload distribution to drive Microbiology, biocompatibility, leachable & extractable and sterilization tests according regulations (c)FDA / EMA / etc. Quotation, planning and delivery. Develop business strategies with Category manager, sales and marketing leaders to build and implement new service and offers in a continuous improvement way. Responsible for Customer Relationship. Management (CRM) and Live cycle management. Manage strategic investments and support customer in IT,OT/Digital projects including, CAPEX OPEX and build offers.

Manager of Project team (up to 8p), Cross Management as Core Team leader of WW and local team members from R&D, Quality, Regulatory Affair, Production, Experts, Support, etc. Accountable on Quality & Regulatory compliance of delivered products. ISO13485, 9001, FDA, BPF, GLP & GMPs. Defining and Managing project time, resources & cost. Management to achieve timeline and budget, ensuring time and risk reduction goals. Follow IQ, OQ,PQ with transfer to customer, CAPA, EHS requierments, etc. Proactively identifying and flagging issues and potential bottlenecks. Close interaction with Sales and Support teams via Salesforce web application (CRM). Managing Project focused on customization and combination product (e.g. Autoinjectors, needle safety device etc.) requested by Customers and Line extension according to internal strategy (business, Marketing, Segment, and Cluster etc.). Collaborate with cross-divisional stakeholders to support Medical Device/ Combination Product technology strategy for Primary Packaging add on, autoinjectors. Synchronize customer with Clinical trials and pharmaceuticals logistics. Main Accountabilities: PMO Process delivery, Design control, DHF, Traceability Matrix, Champion Analysis, “critical to business” commitment and project Milestones, Involved in FMEA, Certification EU/US, CE mark, Patent IP, etc.

Accountable for the system integration of the Molecular Diagnostic Lab automation solution. Define steps of automation with open systems for bMx and competitors. Supervise the development of the DNA automated extractor eMAG®: ensure risks are covered with reliability e.g. on sensors, cameras, Pipettors, and all custom mechanical parts. Manager of integrator team (up to 3p), Cross Management of the project team Software, Hardware, V&V, Biology expert and Technical Support Teams (Level 2-3: GCS & CTS (Global Customer Service & Customer Technical Services). Act as Field Service Engineer with the GCS and CTS teams (Global Customer Service) to transfer knowledge form R&D to field services. Define spare part panels, tools, maintenance and software services. Core team and Steering Committee reporter. Present opportunities, issues and status of the Product qualification. Define the Validation Plan and Strategy. Support the V&V activities to achieve the Validation Project phase following Design Control, DHF, PLM and Standards like IVD ISO 61010, ISO13485 et FDA CFR / CE mark, certification UL, CSA or CMeT. Owner of V&V activities and Traceability Matrix to cover development in V cycle. Collaborate, in multi sites mode, with team based in France (Marcy, La Balme, Grenoble) and in Italy (Firenze). Support international Training and show (Australia, Switzerland, UK, Austria, etc) travel up to 25 %. Extra: Admin Doors and TestTrack® seapine software (Project Traceability matrice) and CAD tools PTC Creo. Team and Technical Hardware Leader, Lab Efficency - Microbiology & Molecular lab Automation. As technical leader Manage Mechatronic team (up to 6p internal & contingent workers) and follow up CMOs and suppliers over Europe e.g. UK, Germany, Liechtenstein, France. Main Accountabilities: Delivery of Prototypes, Beta release, Pre released version and prepare the transfer to production. Selection of technology, software, IHM and follow up of usability testing. Define and work with external supplier / Partner on development contact for automated conveyor solution. Define kind of technology used, type of sensors to manage petri dishes through the whole work flow. Integrate new sensors like Keyence smart sensors – Laser, USound, positioning, Barecode etc. Wrtiter of user specification and user needs URS and supervise design definition and development FDS, SDS, MDS, FAT, SAT, V&V IQ, OQ,PQ etc. Problem report and Issues Management (root cause, fixing, solving according to the criticality and priority), Design control, DHF, Traceability Matrix, Involved in FMEA, Certification EU/US, CE mark, compliance to IEC 61010, UL and IVD standards. Responsible and admin in maintenance of PLM windchill PDMlink.

Development of electroMedical Devices Class II for parenteral and enteral infusion systems (infusion pump / push syringe), linked and connected dock stations and accessories. Following AQ procedures and ISO 13485 - 14971- 60601/ IEC / FDA CFR -510k / CE mark and certifications, UL, CSA, CMeT, Files Submission. Designing Mechanical plastic parts from CAD mechanical prototypes to mold validation and components released. Bring Design for manufacturing expertise: implement first semi-automated assembly line. Work closely with engineering team to install STÄUBLI robots to ensure critical step on final assembly. CoDefine Specifications, URS and bring expertise to cross departments for final FAT, SAT, IQ, PQ, OQ. Support the V&V activities to achieve the Validation Project phase. Owner of the Mechatronic Traceability Matrix accordingly to the V cycle/ Design control. Defining and implementing the HW requirement traceability accordingly to Software procedure and tools. Cross Management of Mechanical designer team – mix of internal position and external contractors. Technical data Management : PLM windchill PDMlink - PTC administrator.

Exclusive development contract for textile implants used e.g. for hernia and up to reinforce skull, ancillary - Class II a/b et III ISO 13485. Work for large accounts and international distributors (e.g. Coloplast®). Product fully compliant to regulation and FDA 21 CFR PART 11 et 510K According to AQ procedures – CE mark files.