Work Flexibility: Hybrid

What you will do:

• Plan, execute, evaluate, and document biocompatibility studies and justifications in support of product safety and performance tests.
• 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 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.
• Support product transfers to other plants/facilities. 
• Review/approve nonconforming material and system documentation.
• Review/approve product and process change control documentation and specifications.
• 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.
• 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 need:

Education:

Bachelors/Master’s degree in biological science or Microbiology

Experience: Minimum 2 years of experience in biological testing, biocompatibility or research and development.

Preferred:

• Relevant experience in 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.
• 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).
• Demonstrated ability to successfully contribute to and lead complex verification / validation test campaigns.
• 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.
• 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.
• Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives.
• Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.
• Experience in working in a compliance risk situation.

Travel Percentage: 10%