Sr Scientist, Biomaterials R&D

Purpose

This role is for a Materials Scientist or Chemist to support the development of new biomaterials technologies and/or support in-market products through their product life-cycle within multiple cross-functional project teams. The Scientist performs prototyping and testing of innovative materials technologies, develops new test methods and manufacturing processes, and supports regulatory submissions. This includes communication with other R&D Scientists and Engineers, Marketing and Sales consultants, and customers e.g., Health Care Professionals. The Senior R&D Scientist will be an integral resource to the R&D team, providing technical expertise on materials science, chemistry, and test methods.

Job Responsibilities

• Support design and development of complex medical devices and projects, providing technical expertise to cross-functional project teams through all phases of the product life-cycle.
• Function as a subject matter expert in biomaterials science and chemistry, and organize, plan, execute and oversee the development of new biomaterials technologies, including support of product development, regulatory filing, product launch, and commercialization.
• Act as a subject matter expert in biomaterials science and chemical test methods.
• Act as a technical team member of a cross-functional project core team (marketing, manufacturing, quality, testing, supply chain, regulatory, etc.).
• Coordinate with design engineers, marketing, quality, supply chain, manufacturing, regulatory affairs, and other functional departments to develop and test new technologies and product concepts.
• Independently develop testing protocols using laboratory instruments, following standard methods or designing custom methods.
• Perform and or coordinate laboratory tasks in a safe manner in analytical, chemical, or biological R&D labs.
• Develop and execute design verification and validation plans and activities, and test plan formation and execution to support global regulatory strategy.
• Support development of intellectual property for novel designs or technologies.
• Collaborate with supply chain, manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and supporting production documentation.
• Design and execute or coordinate scientific experiments, present data and conclusions with appropriate analysis and write technical reports.
• Demonstrate proficiency in the application of statistical methods for test method development and verification and validation activities.
• Understand and follow the New Product Development process accurately and maintains high quality design validation and verifications.
• May be responsible for operating within a budget and provide input on budget allocation and prioritization.
• Perform quality/compliance activities in support of audits, remediation projects, non-conformances, regulatory compliance projects.
• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Qualifications/Requirement

• A minimum of six years of experience in the development or testing of biomaterials based medical devices or combination products.
• MS in Chemistry, Materials Science, Biomedical Engineering, or equivalent required.
• A PhD degree is preferred.
• Experience working in medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirements is preferred.
• A depth of knowledge of biomaterial technologies and chemical test methods is required.
• Strong communication skills - The ability to effectively communicate concepts, ideas and knowledge to upper management, other individuals, customers, e.g., Health Care Professionals and/or teams across the organization is required.
• Ability to work effectively as a technical leader and sometimes as a project leader.
• Possess strong organizational skills to support all aspects of the project management functions including scope definition, budgeting, and contingency planning.
• Excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations is required.
• Must demonstrate a strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience.
• Must have the ability to effectively communicate concepts, ideas and knowledge to other individuals, Health Care Professionals, customers and/ or teams, and work effectively as a technical leader and sometimes as a project leader.
• The ability to review and critically assess patents and other forms of intellectual property is preferred.
• Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.) is required.