About this role

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

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%

Staff Biocompatibility Specialist