Work Flexibility: Hybrid
What you will do:
* Plan, execute, evaluate, and document biocompatibility studies and justifications in support of product safety and performance tests. * Develop technically sound test campaigns, protocols, reports, regulatory summaries, and verification of methods and results in collaboration with project team, test laboratories, and suppliers. * Partners with cross-functional project team members to define evaluation / verification strategies of medical devices. * 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 and execute project plans to include definition of scope, timelines, critical path management, resources, and budget as they relate to biocompatibility. * Interface with key business partners and represent biocompatibility team on new product development teams. * Manage test campaigns (i.e. biocompatibility and chemical testing). * Initiate and communicate best practices and methodologies with Biological Sciences team and cross-functional team members, as appropriate.
What you will need
Required Skills :
* Bachelor's Degree in Engineering or a Science is required; in Chemistry or Biological Sciences preferred. * Experience- 7years – 10 years; relevant experience in a Biological sciences or biocompatibility in the medical device industry. * Possess knowledge and understanding of biocompatibility-related processes and contamination controls, principles, practices, and procedures of the field including ISO standards and compliance. * Direct experience in biological evaluation of medical devices per ISO 10993.
Preferred Skills :
* Demonstrated ability to successfully contribute to and lead complex verification / validation test campaigns; ability to apply design controls within a regulated industry and demonstrated knowledge and ability to apply fundamental and advanced concepts, practices, and procedures regarding biocompatibility. * 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; possess strong analytical skills and be detail oriented and must be computer proficient in Excel, Project, PowerPoint, Word, etc. * 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). * 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 achieve work objectives both independently and as a leader/member of a work team.
Travel Percentage: 10%