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, biological safety evaluations, understanding the impact of manufacturing and/or design changes on material properties and product characteristics and expertise in ISO 10993 standards. This individual will serve as a SME in materials interactions, be it characterization of candidate materials, understanding effects of manufacturing or processing on the products and/or providing input to biocompatibility assessments and related testing. 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.
(essential job duties and responsibilities)
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 leading the development of the Biological Safety Evaluation strategy for each device/change
Responsible for creating & maintaining procedures related to biological safety evaluation processes
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.)
Accountable for robust biological safety evaluation outcomes with technical leadership and sound strategies for successful regulatory submissions
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.
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.
Monitor changes to external standards, regulatory requirements and guidance associated with biological safety evaluation & perform gap analysis to determine continued appropriateness of biological safety results for existing devices.
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:
Broad experience in modern analytical methods (chemical and /or materials)
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 in FDA / ISO regulatory environment for design controls and verification/validation
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 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, Good Laboratory and Good Manufacturing practices (GLP and GMP).
Experience supporting worldwide regulatory submissions
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
Able to develop novel experiments and techniques and to objectively critique results from experiments performed by self and others
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
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 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
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
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
Industrial experience in development of medical devices, pharmaceutical or combinations devices
Knowledge of Food and Drug Administration guidelines and regulations regarding medical 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
The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor