better Job at Edwards Lifesciences Corporation

Documentation Coordinator Req #: 3884 City: Midvale State: Utah Country: USA Function: Quality Responsibilities: Reviews and coordinates the completion of device history records. Responsible for pyrogen/sample submissions to contract laboratories & review of documentation. Responsible for reviewing sterility documentation and release of product to finished goods. Maintains files of DHR and sterility documentation. Creates certificates of compliance, and product verification. Maintains GDP log and initiate NCRs

assurance reviews Perform microbiological testing for medical devices manufacturing processes systems and facilities Work...

Director, Corporate Quality Req #: 3881 City: Irvine State: California Country: USA Function: Quality Responsibilities: . Develops, establishes, maintains and improves quality assurance systems, policies, processes, procedures and controls ensuring that performance and quality of systems conform to established standards and regulatory guidelines. Quality Systems may include, but are not limited to: CAPA, non conformance, software quality assurance, complaint management, document management and corporate policies

Manager Communications Req #: 3869 City: Irvine State: California Country: USA Function: Communications Responsibilities: Visible position reporting to Senior Manager, Communications. This is a great opportunity to play a key role and use your strategic, writing and media relations skills to support Global Communications' efforts to protect Edwards' reputation, grow its leadership and educate key stakeholders. Position Summary: Plan and execute external communications activities that will positively position

Warehouse Clerk Req #: 3867 City: Irvine State: California Country: USA Function: Operations Responsibilities: Work in and support all areas of the Irvine Warehouse operation including Receiving Dock, Raw Materials Stock Room, Finished Goods Quarantine, Return Goods and Shipping. Key duties/responsibilities include: Receive, identify and stage materials for the Irvine campus using computerized receiving applications. Deliver materials to various locations on the Irvine campus. Issue material for work orders

Technical Supervisor Req #: 3868 City: Irvine State: California Country: USA Function: Quality Responsibilities: Exceptional growth opportunity for an engineer on the Operations Management career path. This position is a key hands-on leadership role for the HVT Quality organization in the mechanical manufacturing areas. Will have primary responsibility for the implementation of quality system requirements in LFS manufacturing, including training and supervision of inspection staff, process validation activities

Engineering Technician Req #: 3863 City: Anasco State: Puerto Rico Country: USA Function: Engineering Responsibilities: Perform significant assignments of specific related tasks, which are typically a phase of a large project; plan details of assigned tasks within specific parameters. Provide technical support to local engineering staff with methods, practices and improvements programs. Solves practical problems encountered in fields of specialization executing engineering functions required. Essential Duties

Experience with Class II medical devices cardiovascular devices is a plus...

EW Manufacturing Staff Engineer Req #: 3855 City: Irvine State: California Country: USA Function: Engineering - Manufacturing Responsibilities: Manufacturing engineering position that leverages medical device manufacturing experience for line support, process control and development associated with latex balloon and medical device manufacturing. Responsible for the technical aspects of latex compounding and natural latex balloon manufacturing production. Identify and implement engineering projects to reduce

Requirements 8 years of experience in Pharma or Medical Devices...

Network Engineer II Req #: 3842 City: Irvine State: California Country: USA Function: Information Technology Responsibilities: *Multi-level position: Position title and level posted is preferred. However, we will consider hiring at the Sr. Telecom Specialist level. o Configure, deploy, fine tune, and monitor firewalls, routers, switches, WLANs, security information and event management systems, intrusion detection/prevention systems, vulnerability scanners, multi-factor/strong authentication technologies, VPN

in the commercialization of innovative complex medical devices i e 510k IDE PMA...of global regulatory requirements for cardiovascular medical devices including surgical and interventional devices products...

Assistant Marketing Req #: 3835 City: Nyon State: Switzerland Country: Switzerland Function: Marketing Responsibilities: Role Purpose: Assist the Edwards Lifesciences European THV Marketing Departement in administrative and organizational tasks Major Job Functions: - Organisation of all related to THV Meetings - Mailings - Inter-company rebilling - Day to day administrative work (photocopy, scan, UPS, various correspondences, flights and hotel bookings for HVT Team, etc.) - Registration for congresses and hotels

Staff Engineer Req #: 3829 City: Irvine State: California Country: USA Function: Research & Development Responsibilities: Provide engineering expertise to transcatheter heart valve (THV) R&D team in the design and development of novel based products (catheters, delivery systems) for the transapical procedure in support of company's strategic plan. Generate design concepts, prototype builds, pre-clinical evaluations, and transfer of product to manufacturing. Apply mechanical engineering knowledge to the design

Requirements Requires a minimum of three years selling experience preferably selling implantable medical devices...

Job Functions Sells the company s medical devices products by interacting with established larger...

Marketing Specialist Req #: 3865 City: Irvine State: California Country: USA Function: Marketing Responsibilities: Handle all Product and Brand manager requests for materials, information and event logistics; prepare and package presentations; maintain calendar and activities essential to the completion of timely projects. Perform projects including preparation and coordination of conferences and tradeshows events, event planning and facilitating preparation/packaging of any and all communication/sales pieces

Document Associate Req #: 3864 City: Irvine State: California Country: USA Function: Clinical Affairs Responsibilities: Provides clerical and administrative support related to clinical study documentation. Responsible for efficient processing of study documents, maintaining tracking logs and filing. Interacts with various inside/outside groups to facilitate clinical trial research. Responsibilities include but are not limited to: .Development and maintenance of in-house master study files and site study files

Manufacturing Supervisor Req #: 3862 City: Anasco State: Puerto Rico Country: USA Function: Engineering - Manufacturing Responsibilities: Under the direct supervision of the Manufacturing Business Unit Manager, the incumbent supervises manufacturing operations. With his/her group of group leaders and operators, the incumbent is responsible for compliance with current Good Manufacturing Practices, as well as local, federal, and international EHS and other rules and regulations (SOX, ISO, etc.), as well as company

Lean Sigma Staff Engineer Req #: 3845 City: Anasco State: Puerto Rico Country: USA Function: Operations Responsibilities: The Lean Sigma Staff Engineer applies standard and advanced engineering principles to drive basic and complex Lean Sigma events and projects, from conception to final implementation. Identifies, plans, schedules and leads project assignments requiring independent judgment in the evaluation, selection and adaptation of various engineering techniques, procedures and criteria. Under the direct

Sr. Safety Clinical Research Associate Req #: 3840 City: Irvine State: California Country: USA Function: Clinical Affairs Responsibilities: Exciting opportunity with the world leader in Heart Valves to advance patient care through clinical research on our Transcatheter Heart Valve Program. As a Senior Safety CRA, you will be responsible for the following: - Adverse Event handling and reviewing, according to SOP, European and FDA regulatory requirements - Determining event reportability, based on serious criteria

Benefits Specialist Req #: 3844 City: Irvine State: California Country: USA Function: Human Resources Responsibilities: Responsible for tracking and answering all employee benefit related questions and emails that come through to the Edwards Benefit Service Center (EBSC); resolving all employee claims issues; providing quarterly EBSC utilization reports; processing death/beneficiary forms and maintaining form centers/kiosks. Other key responsibilities: Conduct employee new hire orientation Manage quarterly

Information Systems Analyst Req #: 3640 City: Irvine State: California Country: USA Function: Marketing Responsibilities: The analyst would be a key member of the Business Intelligence team for the Heart Valve Therapy business unit. Specifically, the analyst would focus on supporting the Marketing, Sales, Regulatory, and Quality departments by performing technical analyses of clinical registry data. This would entail: .Synthesizing registry data with data from internal sources (e.g. sales data, complaints data

Sr Technologist Req #: 3839 City: Irvine State: California Country: USA Function: Engineering - Manufacturing Responsibilities: This is an exciting opportunity in the Critical Care Business with the Corporate Manufacturing Engineering Team. The Team is currently involved in developing and implementing new Process Methods and Technology. On this challenging role you will help define how to manufacture and modernize the manufacturing of the Pressure Monitoring Catheters in the Caribbean and Balloon Manufacturing

Product Development Staff Engineer Req #: 3832 City: Irvine State: California Country: USA Function: Research & Development Responsibilities: This is an opportunity to become a member of a high performance cross functional product development team developing a revolutionary new way to implant heart valves. This position will be involved in the design, development, testing and implementation of delivery systems and accessories for heart valve implantation procedures. Key responsibilities include: .Work as part

Must have experience in the development of medical devices...

Clinical Sales Specialist Req #: 3824 City: Brussels State: Belgium Country: Belgium Function: Sales Responsibilities: 1. Provide clinical training and guidance to the THV customers , ensuring effective support for the THV team, clinicians, technicians for commercializing sites in Europe 2. Be responsible for implants performance on the given territory 3. Be responsible for education efficiency and independence 4. Create and develop THV market in the given territory. He/She will have to achieve the sales target

Principal Engineer Req #: 3791 City: Irvine State: California Country: USA Function: Engineering - Manufacturing Responsibilities: Provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease. Conduct engineering activities from initial product development phase through product launch. Develop enabling manufacturing technologies to meet new product demands. Conduct process development activities including design, specification

EW Sr Engineer Req #: 3782 City: Irvine State: California Country: USA Function: Engineering - Manufacturing Responsibilities: Will drive process control and quality assurance through process documentation, standards of work, process FMEAs, quality plans and training plans. Evaluate and implement process improvements to stabilize new production processes. Will conduct make/buy analyses to enable operations and supply chain strategy. Drive supplier identification, evaluation, selection and qualification processes

Clinical Research Associate (Irvine, CA based) Req #: 3767 City: Irvine State: California Country: USA Function: Clinical Affairs Responsibilities: This is an exciting opportunity within our Critical Care division to advance patient care through clinical research. We are looking for a highly motivated individual to work in our rapidly changing and expanding Critical Care Division. This is a fast paced environment with many studies in progress and planned for the near future. As a CRA, you will be responsible

and clinical engineering of cardiac implant medical devices with 10 15 years of relevant...

Junior Accountant Req #: 3784 City: Prague State: Czech Republic Country: Czech Republic Function: Finance and Accounting Responsibilities: Perform intercompany reconciliation and reconciliation of balance sheet accounts. Book/settle local (Czech Republic)incoming/outgoing invoices. Cooperate on regular credit control check - participate on reviewing credit limits for customers. Communicate with customers and Head office. Develop internal procedures in compliance with statutory and Sarbanes-Oxley Act requirements

Clinical Research Associate II Req #: 3783 City: Irvine State: California Country: USA Function: Clinical Affairs Responsibilities: Selected candidate will be responsible for the following: . Develops and maintains liaison and oversight among outside physicians, supporting staff, administrators including clinical investigators, medical educators, and department heads in medical schools, affiliated hospitals, state and/or government hospitals, and research institutions to initiate and expedite clinical studies

Territory Mgr HVT South Center Italy Req #: 3790 City: Milano State: Italy Country: Italy Function: Sales Responsibilities: - Work with the BU Manager to assist in defining sales targets, and overall goals for his/her team. Assist in the process of budgeting, sales forecasting and expenses planning. - Responsible for developing and executing marketing and sales initiatives to ensure the sales objectives are met in his/her territory. - Lead, train and motivate a team of sales reps covering the assigned product

Sales Representative THV Denmark & Norway Req #: 3788 City: Copenhagen State: Denmark Country: Denmark Function: Sales Responsibilities: Responsible for creating and developing THV market in Denmark and Norway under the supervision of the THV Business Unit Manager Nordic (performance will be measured against predetermined and agreed targets, both sales and otherwise). Primary responsibilities: .Acquire a thorough working knowledge of the products/therapies and procedures; develop an extensive understanding of

R&D Engineer Req #: 3781 City: Irvine State: California Country: USA Function: Research & Development Responsibilities: Provide engineering support to the Advanced Technology Organization and other Edwards Lifesciences business units in the design and development of cardiovascular devices. Will interface with R&D project teams to establish their needs and assist them in designing implants and delivery system device components. Further responsibilities are to develop laser cutting programs for implants and other

Business Unit Manager Critical Care Req #: 3780 City: Madrid State: Spain Country: Spain Function: Sales Responsibilities: This position reports to the Sales Director of Europe Critical Care. Role Purpose: . Provide business support to the country. Primary responsibilities include direct sales activities, pricing, account prioritization (in the given territory). . Responsible for coordinating commercialisation across a given territory with customers, EU marketing, training and clinical organizations. . Responsible

Sr Technologist Req #: 3778 City: Irvine State: California Country: USA Function: Research & Development Responsibilities: This is an exciting opportunity with an Advanced Technology team, currently involved in developing a new transcatheter heart valve application. On this innovative team, you will be responsible for providing support to the R&D and manufacturing engineering groups. Key Responsibilities to include: -Assist R&D engineers with device development including: rapidly prototyping designs, evaluating

BUM HVT MIS Req #: 3699 City: Milano State: Italy Country: Italy Function: Sales Responsibilities: Under the general direction of the HVT Sales Director of Southern Europe, this role oversees the given business managing sales & marketing of his/her commercial division; including deployment of marketing strategies, achieving sales objectives through prioritizing sales activities, pricing negotiation, controlling marketing expenses and managing the sales team. Represents the company in the field through strong

Sales Representative THV (Transcatheter Heart Valves) Req #: 3687 City: Unterschleissheim State: Germany Country: Germany Function: Sales Responsibilities: . Establish customer contact and strengthen relationship to create and protect THV business . Drive penetration of THV products in the given territory . Give Edwards THV a face in the market . Create new business with new customers . Observe marketing environment and execute the Edwards marketing and product launch strategy . Responsible for achieving sales

- - Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company has more than 6,200 employees worldwide

- - Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company has more than 6,200 employees worldwide

Experience in Interventional Medical Devices 510K PMA Products required as well as solid knowledge of plastics...

Clinical THV Manager Req #: 3600 City: St-Prex State: Switzerland Country: Switzerland Function: Clinical Affairs Responsibilities: Role & Responsibilities: -Responsible for developing and conducting global post-commercial clinical trials/studies/registries on Edwards Lifesciences' products and to ensure compliance with any EU or other applicable regulatory body regulations. -Develop and maintain liaison among physicians/investigators, other medical professionals. --Research Organizations (CRO's), hospitals

care through the development of innovative medical devices...

- - Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company has more than 6,200 employees worldwide

- - Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company has more than 6,200 employees worldwide

VMware Administrator Req #: 3511 City: Irvine State: California Country: USA Function: Information Technology Responsibilities: Will have global responsibility for VMware virtualization platforms, VMware architecture and troubleshooting, system maintenance, tuning, troubleshooting operating system problems and new hardware implementation, particularly Edwards' Windows 2003 Active Directory, Backup, Storage, and Exchange 2007 environments. Primary duties include guiding team in managing global technologies such

Proven knowledge of FDA GMP ISO requirements regarding medical Devices...

Director / Senior Manager Communications & Branding EMEA Req #: 3712 City: St-Prex State: Switzerland Country: Switzerland Function: Communications Responsibilities: Role Purpose: Responsible for the design, implementation, execution, and coordination of the communications strategy and activities for the EMEA region and for all the businesses (THV, HVT, Critical Care and CSS) in line with the Corporate guidelines and strategy. Manages the communications team - including the BMP activities. Belongs to the EMEA