The Senior Scientist (P3) is responsible for technology development and executing the project plan activities for assigned new product development projects while ensuring compliance to design control processes and external regulatory guidelines. The position may lead small projects with manageable risks and resource requirements.
· Design and develop Core Histology Consumable products, including new technology development, feasibility study, optimization, verification, validation, design transfer, and final product development. Achieve milestones of stage gate development process.
· Maintain quality standards of FDA, ISO, GLP and GMP.
· Prepare technical WIs as required for review and approval.
· Participate in design change and manufacturing cost improvement initiatives.
· Provide scientific and technical supports to regulatory, marketing, manufacturing, and sustaining.
· Write and/or publish scientific and technical documents, meeting abstracts.
· The position may lead small projects with manageable risks and resource requirements.
· Other duties as assigned.
Required Education, Experience, Skills
· Bachelor, Master or PhD Degree (or Equivalent) in physical, biological, or material science, such as polymer, chemistry, biology, histology or physics.
· PhD degree, MS degree) in Medical Product Design and Development.
· Computer skills; Microsoft Office software, statistical software.
· Experience in preparation of controlled studies, protocols, statistical analysis and report writing.
- Use of science and/or engineering knowledge and research to critically evaluate and develop test methods and procedures for testing.
- Preferred experience/Skills:
A. Experience in academic, medical device or pharmaceutical environments with diagnostic products.
B. Knowledge of the chemical composition, structure, and properties of glass, fixative, wax, histology staining, polymers and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, production techniques, and disposal methods.
C. Experience leading cross-functional teams from design through commercialization of new medical device products.
D. Experience in Design of Experiment.
E. Experience in a Clinical setting, Histology, Tissue processing.
· Ability to manage priorities in a fast-paced environment.
· Capable of working effectively independently or in a team environment in order to meet goals and objectives.
· Ability to communicate effectively both verbally and in writing.
· Excellent proficiency with software applications such as Microsoft Office.
· Exceptional organizational skills.
· Results and details oriented and high level of commitment
· Ability to lead small projects.
· Conceptual and practical expertise in core histology consumable products.
· Ability to use best practices and knowledge of internal or external business issues to improve our products.
· Ability to solves complex problems; takes a new perspective using existing solutions.
· Ability to explains difficult or sensitive information; works to build consensus.
· Stage gate design control experience in highly regulated development and manufacturing environments.
· A proven track record of contributing to new product development projects from design through manufacturing as scientist.
· Excellent attention to detail as well as big picture focus.
· Flexible and able to prioritize competing issues.