Stéphane Moreau, Eng., M.A.Sc., Mba Email & Phone Number

Minneapolis, Mn, Us

Minneapolis, Mn, Us

• Responsible for directing and controlling activities related to Cryo ablation catheters with overall responsibility for the direction of those assigned areas. Determine actual organizational structures and allocation of subordinate management responsibilities.• Responsible for the overall surveillance and operational success of assigned functions and for cross functional collaboration with manufacturing operations, marketing, sales, quality, regulatory and clinical functions.• Participate with other management in developing, establishing division, group, company, or corporate-wide policies.• Provide functional and/or project vision and leadership of group toward setting and meeting business goals.• Lead implementation of advanced design and engineering methodologies, techniques, and evaluation criteria.• Direct the development of strategic plans across multiple disciplines.• Direct alignment with core business leaders and ensure execution with proper resources (skills, abilities, talent) across multiple disciplines.• Select, develop, and evaluate personnel to ensure the efficient operation of the function.• Responsible for decisions affecting the success of the division, group, company and corporation. Erroneous decisions would normally result in failure to achieve critical goals and objectives.• Provide cost center planning and management.• Responsible for leadership of AF Solutions cryo ablation catheter developments efforts.• Responsible for developing and continuously improving a world-class catheter technology development process, design environment, and leadership staff.• Able to assign resources based on business knowledge under the stress of dynamic business conditions• Technical skills adequate to understand risk and scale investments appropriately• Commitment to functional excellence and the ability to execute positive changes.• Able to create and manage key internal and external partnerships

Minneapolis, Mn, Us

The Sr. Manager is responsible for managing the team to meet schedule, scope, and budget of a project.Administers and supports projects using process standards and methodology. Provides expert leadership regarding project management standard practices.Creates, coordinates and controls project management documentation (paper & electronic).Plans project tasks to meet objectives.Assists in the management of relationships with suppliers, consultants, contractors and internal personnel to meet project objectives and schedules.Monitors project budget using earned value method of project reporting.Communicates project status.Regularly reviews and measures work against project objectives. Responsible for addressing assigned CAPA activities and ensuring that established timelines are met.

The lecturer is responsible to organize and deliver lectures, tutorials and consultations in Project Management and other related areas. Other main areas of responsibility include syllabus planning and development, course management, class management, student assessment and implementation of teaching and learning strategies of Project Management applied in the biopharmaceutical industry. The medical devices class is an introduction to the various regulatory paths for different types of devices throughout the world. Quality of life indexes are also being looked at. Those courses are offered as part of the DESS (Diploma d’Études Supérieures Spécialisées) in drug development at the Faculty of Pharmacy of the Université de Montréal.

Montréal, Québec, Ca

The Scientific Advisory Board Members are elaborating the rules and structures for project tenders between the Industry, the Universities and all other stakeholders. They are also reviewing the tenders and determining or not they qualify for financing by the consortium.

The Senior Director, Project Management is responsible for guiding and mobilizing his team members; for developing, supporting and guiding the department in order to render the organization’s strategy functional to achieve expected results. The Senior Director, Project Management is directly supervising various teams including: Project Managers, Report & Reprography Agents, SOP & Investigations Specialists and, Administrative Support Assistants.He is also responsible of the division budget and development strategies whether it is for the training of employees or for their development as individuals.The teams are located on 3 different sites; Québec City (QC), Montréal (QC) and Toronto (ON).

Same as Associate Director plus involve in corporate strategic initiatives, portfolio management and global budgets. Manage the Operations Committee where all the organization directors are involved.

2007Description: Direct and structure the operations of his sector according to the operational needs of the division/service. Plan the required human resources within his sector, assess the performance of his team and establish with them a development plan that will lead to an improvement of their effectiveness. Participate in the preparation of the budgets of his sector and ensure the follow-up. Ensure the smooth running of his sector and carry out all monitoring activities required by this responsibility. Establish and analyze the performance indicators of his division/service in relation to with the strategic objectives of the organization, the resources and the potential of his division/service; assess and control the results and take the actions that are necessary. Evaluate opportunities to improve the activities of his division/service and, if needed, determine the actions required to achieve a greater effectiveness. Communicate and present all necessary information to his team and the organization regarding plans for the division/service, policies, projects, procedures, results, actions taken and recommendations made to meet needs. Manage the operational activities of the project managers, assign the projects and the clients to the various project managers, determine the priority of the projects if needed and develop tools to make the work of the project managers easier and to assess their work. Communicate with the clients when problematic situations arise. Write and revise the SOPs that are used by the project managers in their work. Hire the project managers according to the organization's needs and assess their performance. Act as the division's representative towards the operations committee.

2006Description: Prepared tenders for projects of bioequivalence and phase I trials. Revised clinical research protocols, informed consent forms, amendments and administrative letters. Established the project charts and ensured the follow-ups so that the schedules, the specifications of the sponsor and the clinical research protocol were respected. Been the point of contact between the sponsor and all project team members and various internal team members. Made reports to the sponsor during the course of each project. Guided staff involved in clinical, analytical and statistical aspects of the projects. Coordinated multiple projects altogether with their timelines and their specific requirements. Took care of clients when visiting Anapharm's facilities.

Prepared tenders for projects of phase II to IV as well as pharmacoeconomics studies. Developed clinical research protocols, informed consent forms, case report forms, amendments, CTA (Clinical Trial Application) and administrative letters. Planned the project schedules and ensured the follow-ups so that the schedules, the specifications of the sponsor and the clinical research protocol were followed. Made reports to the sponsor during the course of each project. Managed staff involved in clinical, analytical and statistical aspects of the projects. Managed multiple projects altogether with their timelines and their special requirements.Developed all required procedures (SOP) to be GCP (Good Clinical Practices) compliant;Elaborated pharmacoeconomics procedures and submitted the reports within established timeframes and budgets;Developed clinical protocols, CRFs, patient questionnaires as well as all other documents within timeframes and with high quality criteria.

Description: Designed spinal implants, evaluated and validated all steps required for their manufacturing. Designed and implemented the manufacturing processes. Implemented ISO standards and obtained accreditation. Obtained CE mark for devices to be commercialized in Europe. Managed clinical studies for medical devices (equivalent to phase III for drugs). Prepared regulatory documents for CTA (Clinical Trial Application) both for US & Canadian agencies. Wrote and developed clinical research protocols, informed consent forms, amendments, case report forms and administrative letters. Performed site recruitment and qualification for medical device trials. Recruited surgeons and participated to scientific and commercial international meetings. Planned the project schedules and ensure the follow-up so that the calendar, the specifications of the product and the clinical research protocols were followed. Negotiated prices with different suppliers from primary goods to CRO (Contract Research Organization). Made reports to the management during the course of each project. Managed staff involved in clinical, technical and statistical aspects of the projects.Developed spinal implants and completed projects within established timeframes and imposed budgets;Submitted 2 IDEs (Investigational Device Exemption) to the FDA and obtained approvals following the first 30 days of submission (minimum delay);Put in place procedures to meet ISO standards (9001 and 13485) and obtained accreditation at first attempt;Submitted 2 requests for clinical trials at Health Canada and obtained approvals;Negotiated contracts with CROs (Contract Research Organizations). Contract values varying between 250,000$ and up to more than 1,000,000$;

Description: Designed and developed new equipments to be added to the company's fuel cell systems. Proposed new alternatives to supplement to actual equipment. Significantly decreased the manufacturing costs. Increased the overall system power efficiency. Managed staff (up to 18 employees) involved in technical and practical aspects of the project development. Developed company's new products. Recommended components for the fuel cell systems. Met suppliers and negotiated prices. Managed prototype assays and supervised a multidisciplinary team.Developed new products within established timeframes and imposed budgets;Negotiated contracts with suppliers, write legal documents and obtained long-term agreements;Managed prototype tests and obtained system functionalities within prescribed delays;Managed a multidisciplinary team and obtained the support of everyone;Optimized the manufacturing process and significantly decreased costs;Gave training to the firm's clients and obtained their satisfaction.

Montréal, Québec, Ca

Responsible of teaching the Méthodologie des Projets d'Ingénierie et Communications to first year engineering students.Described relevant methods for engineering projects completion within timeframes and budgets.

Montréal, Québec, Ca

Description: Analyzed samples made of various materials using characterization tools like, SEM (Scanning Electronic Microscopy), TEM (Transmission Electronic Microscope), and CA (Contact Angle) measurement to determine the surface energy, composition and topography of a solid. All those measures were taken to evaluate if a given surface has been modified through a direct gas plasma sterilization process. Results were transmitted to a doctorate student. Responsible of tests related to catheter surface modifications following gas plasma sterilization treatments.Met required timeframes and submit reports;Collaborated to scientific articles writing;Participated to various international biomaterial conferences;Participated to SIBA elaboration (Symposium International sur les Biomatériaux Avancés) that took place in 1997 in Montréal.

Responsible for the development of a new plasma-based sterilizer.Developed a brand new sterilization system to reproduce the work accomplished in Montréal and obtained tremendous results;Managed a technician and obtained his entire collaboration;Collaborated with the CRSSA; at La Tronche as well as with the Université Joseph-Fourier of Grenoble.

Team Mobilisation In Service Organizations

Mba, Management & Finance

M.Sc.A., Biomedical Engineering

Engineering, Physics

Dec, Health Sciences & Administration

Des, General