Edwards Lifesciences Senior Scientist, Research & Development in Irvine, California
The Senior Scientist, Research & Developmen t will plan and implement technical laboratory experiments/returned product evaluations, which may include providing feedback and suggestions based on experimental results. Contribute to the experimental planning process and advance research/manufacturing process.
Hands-on use of LC-MS and other analytical laboratory equipment including test method development, study design, and data interpretation.
Design and conduct/lead cross-functional and/or independent investigational studies which may include in vivo and/or in vitro multiple biochemical or biomechanical testing, for the evaluation of medical devices or components. The tasks may also include preparing quantitative analyses, technical summary reports, observations, conclusions, and drafting recommendations for project leader to review. Maintain accurate and complete records, methods, measurement, and observations related to assigned projects/evaluations throughout the process. Can assume team and sub-project leadership role under manager/director sponsorship Recommend and/or provide input to the expense budget estimating process and purchases of capital equipment.
Conduct, design, and/or test IQ (Installation Qualification)/OQ (Operational Qualification) for equipment qualifications, as well as test method validations. Can play a significant role in PQ/PPQ development and execution.
Train other analytical testing and engineering personnel, and may review the work of lower level Research Associates and other engineers.
Improve existing processes and develop new SOPs. May contribute to product and process innovation through IRs (Invention Records) and patent development.
Attend and/or conduct cross-functional meetings to review returned product evaluations, providing scientific input.
Other incidental duties assigned by Leadership
Education and Experience
Bachelor's Degree in a scientific discipline and 4+ years of experience working in a medical device, pharmaceutical industry and/or lab environment - OR -
Master's Degree in a scientific discipline and 3+ years of experience working in a medical device, pharmaceutical industry and/or lab environment
Ph.D. in analytical chemistry or related field preferred
Proven expertise in usage of MS Office Suite
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Basic project management skills
Substantial understanding and knowledge of principles, theories, and concepts relevant to a laboratory environment
Strong problem-solving, organizational, analytical and critical thinking skills
Substantial understanding of processes and equipment used in assigned work
Good leadership skills and ability to influence change
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to medical device manufacturing
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.