Staff Biocompatibility Specialist

Overview

Staff Biocompatibility Specialist responsible for planning, executing, evaluating and documenting biocompatibility studies and justifications in support of medical device product safety and performance tests.

What you'll 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.
• Partner with cross-functional project team members to define evaluation and 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.
• Identify critical process factors and their effects on biological safety.
• Develop and execute project plans including definition of scope, timelines, critical path management, resources, and budget as they relate to biocompatibility.
• Interface with key business partners and represent the biocompatibility team on new product development teams.
• Manage test campaigns (i.e. biocompatibility and chemical testing).
• Initiate and communicate best practices and methodologies with the Biological Sciences team and cross-functional team members, as appropriate.

What you'll need

• Bachelor's Degree in Engineering or a Science is required.
• 7 to 10 years of relevant experience in biological sciences or biocompatibility in the medical device industry.
• 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.

Nice to have

• Degree in Chemistry or Biological Sciences.
• 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.
• Team oriented, with the ability to motivate and work well with diverse cross-functional teams; strong analytical skills, detail oriented, and 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 functions (i.e. Manufacturing, Quality, Regulatory, Design, Sourcing).
• Excellent verbal and written communication and interpersonal skills to interact effectively with 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 or member of a work team.

Details

• Work mode: Hybrid.
• Location: Gurugram, India.
• Travel: 10%.