This position is responsible for participating in the innovation and creation of new and novel user solutions. Key focus areas for this position are biocompatibility assessments, expertise in ISO 10993 standards, understanding the impact of manufacturing and/or design changes on material properties and product characteristics. This individual will serve as a SME in materials interactions, be it providing input to biocompatibility assessments and related testing, understanding effects of manufacturing or processing on the products and/or characterization of candidate materials. This individual will assess and analyze the appropriateness of existing data to support new applications or uses of existing materials and determine if additional data is required. Participation and execution of related regulatory strategy, identification and assessment of novel technologies and new products as well as advancing the understanding of wound healing are also important aspect of this position as a successful candidate is expected to develop and communicate critical aspects associated with the manufacture of and science behind Acelity’s products to regulatory agencies, technical colleagues and lay people.
Principle Responsibilities: (essential job duties and responsibilities)
- Responsible for leading the development of the Biological Safety Evaluation strategy for each device/change
- Responsible for creating & maintaining procedures related to biological safety evaluation processes
- Accountable for robust biological safety evaluation outcomes with technical leadership and sound strategies for successful regulatory submissions
- Participate in design and risk review meetings to address device biological safety concerns and ensure the proper records of biological safety assessments and test plans/reports.
- Collaborate and clearly communicate with internal and external stakeholders (e.g. Board Certified Toxicologists, Contract Research Organizations (CROs) to ensure appropriate planning and execution of risk assessments and required testing.
- Review biocompatibility test results to determine adequacy of data to meet requirements (such as ISO 10993 and other applicable standards) for the biological effects, and utilize problem solving skills and technical knowledge to troubleshoot unexpected results.
- Serve as the subject matter expert for applicable external standards and regulatory requirements for the biological safety of medical devices.
- Responsible for working with cross-functional project teams to assess impact of source material, design and manufacturing changes to both current products and those in development. Provide input and data to minimize risks associated with changes (chemical, physiological, etc.)
- Support regulatory submissions to global regulatory agencies in areas associated with materials characterization and testing, to include biocompatibility strategy and data in response to additional information requests.
- Responsible for appropriate input, design, implementation, analysis and reporting of experimental studies
- Responsible for transferring information gleaned from experiments and technology projects to both technical and non-technical parts ot the organization
- Responsible for appropriate generation and protection of intellectual property
- Participates in any and all work activities as may be deemed suitable and assigned by management
- Conforms to, supports and enforces all Company policies and procedures
Skills and Experiences:
- Experience developing and driving biocompatibility and biological safety evaluation strategies with scheduled and defined dependencies between tasks and deliverables for inclusion with worldwide regulatory submissions.
- Extensive knowledge of FDA and ISO 10993 biological safety requirements and test methods, design controls, verification/validation, Good Laboratory and Good Manufacturing practices (GLP and GMP).
- Experience supporting worldwide regulatory submissions
- Experience, skill and/or knowledge in the following, including but not limited to: materials evaluation and chemical characterization (e.g. DSC, FTIR, HPLC, UPLC, GC, SEM, EDAX, NMR, TGA, DMA, rheology, ion selective electrodes, etc.), mechanical testing (e.g. tensile testing, lap shear, torsion, 4-pt bend, compressive strength, impact, etc.). Experience with evaluation of biomaterials and tissue a plus.
- Able to troubleshoot complex problems with equipment or results outcomes
- Experience and broad knowledge of adhesives, thin films, polymers, polyurethanes, silicones, superabsorbents
- Experience and broad knowledge of manufacturing techniques used to convert and/or produce medical devices (welding, molding, extrusion, bonding, casting, solution precipitation, plating, etc.)
- Experience designing, executing, analyzing and documenting protocols and experiments.
- Proven experience with project management skills.
- Capable of integrating results from various studies and utilize the information to perform follow on work
- Experience with software germane to technical area of expertise (such as laboratory information management systems, databases, finite element analysis, data capture, etc.)
- Able to communicate effectively, both verbally and in writing to both technically sophisticated and lay audiences
- Well organized
- Closer – Drives to Completion
- Collaboratively participating in cross functional teams. Leading small cross-functional teams a plus.
- Independent trouble shooter
- Minimum 7 years experience in or with FDA/ISO regulated industry, substantial relevant experience in academic settings during training will be considered in lieu of experience.
- Minimum 4 years experience participating in development and execution of biocompatibility or biological safety assessments
- Proven understanding and application of principles, theories and concepts in biocompatibility per ISO 10993
- Minimum 4 years experience working with product development teams to assess impact of manufacturing changes on materials/product characteristics
- Proven understanding and application of principles, theories and concepts associated with assessing polymers and adhesives
- Proven experience with biologic test methods or pre-clinical experimental design and execution
- Proven ability to adapt industry standards and best practices for internal use
- Ability to conduct statistical analyses and present data
- Broad command of computer applications for documentation and data management (Excel, Word, Powerpoint, etc.)
- Able to deal effectively with all employees and external business contacts while conveying a positive-service-oriented attitude
- Ability to completely maintain confidentiality and discretion in business relationships and exercise sound business judgement
- Able to travel as needed
- PhD with 4 years industry experience and/or MS with 7 years industry experience
- Knowledge of Food and Drug Administration guidelines and regulations regarding medical devices
- Industrial experience in development of medical devices, pharmaceutical or combinations devices
- Knowledge or experience with fluid transport and/or hydraulics a plus
- Active participation in internal and external scientific standard organizations (ISO, ASTM, etc.)
- Bachelors degree in bioengineering, biomedical engineering, biomaterials, chemical engineering, chemistry, polymer engineering, polymer chemistry, materials science & engineering, mechanical engineering or any technical area leading to skills required to succeed
- Post-graduate degree a plus