Senior Biocompatibility Specialist
Work Flexibility: Hybrid What you will do: Plan, execute, evaluate, and document biocompatibility studies and justifications in support of product safety and performance tests. And support product transfers to other plants/facilities. Partners with cross-functional project team members to define evaluation / verification strategies of medical devices and review, evaluate, interpret, and apply internal and external guidance documents as they relate to biocompatibility.
Identify and analyze materials, design, and process challenges to achieve optimal solutions that satisfy cost and technical requirements as they relate to biological safety. Responsible for identifying critical process factors and their effects on biological safety.
Develop technically sound test campaigns (i.e. biocompatibility and chemical testing)., protocols, reports, regulatory summaries, and verification of methods and results in collaboration with project team, test laboratories, and suppliers; develop and execute project plans to include definition of scope, timelines, critical path management, resources, and budget as they relate to biocompatibility.
Review/approve nonconforming material and system documentation; product and process change control documentation and specifications and interface with key business partners and represent biocompatibility team on new product development teams.
Make positive contributions, recommend approaches, and support updating / developing internal procedures that comply with applicable global regulatory requirements. Be the point of contact for suppliers/development engineers for new process development, quality issues and process improvements for assigned projects.
Participate in the development and improvement of the manufacturing processes for existing and new products and actively participate on teams to support new product development activities. Support design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
Ensure effective implementation and compliance to all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process. What you will need: Required Skills: Bachelors/Master’s degree in Biological Science, Microbiology, Chemical Engineering or Related Sciences; minimum 2 years to 5 years of experience in biological testing, biocompatibility or research and development.
Experience: 5 years - 7 years Possess knowledge and understanding of biocompatibility-related processes and contamination controls, principles, practices, and procedures of the field including ISO standards and compliance and direct experience in biological evaluation of medical devices per ISO 10993 and compliance risk situation.
Demonstrated ability to draw conclusions, present and make recommendations based on analytical data and technical inputs from multiple and varied functions (i.e. Manufacturing, Quality, Regulatory, Design, Sourcing) and ability to successfully contribute to and lead complex verification / validation test campaigns.
Preferred Skills: Relevant experience in medical device industry and experience with medical device product development lifecycle, including risk management and design/process verification and validation. Capable of developing and driving to a detailed project plan with scheduled and defined dependencies between tasks and deliverables.
Must be team oriented, with the ability to motivate and work well with diverse cross-functional teams. Excellent communication skills, both verbal and written, and interpersonal skills to effectively and professionally interact with and contribute constructively to a global team environment, outside departments and externally.
Demonstrated ability to lead complex initiatives from concept through release and understand the fundamentals of at least one of the following sterilization techniques: gamma irradiation, ethylene oxide (preferred), hydrogen peroxide gas plasma, moist heat, or dry heat and be an expert in one of the techniques and ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives.
Travel Percentage: 10%