The Senior Scientist, Research & Development will develop analytical test methods using techniques such as LC-MS, HPLC, and colorimetric assay, and develop novel concepts for chemical treatment of collagenous tissue and polymers. This scientist 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
- Hands-on experience of LC-MS and other analytical laboratory equipment including test method development, study design, and data interpretation.
- 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 is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.