Lead Biocompatibility Engineer / Lead Toxicologist

Lead Biocompatibility Engineer / Lead Toxicologist

Job Title: Lead Biocompatibility Engineer / Lead Toxicologist
Contract Type: Permanent
Location: California, USA
Salary: Negotiable
Start Date: ASAP
Reference: 324573_1550629023
Contact Name: Reece Mitellas
Contact Email:
Job Published: February 20, 2019 02:17

Job Description

Responsibilities and Accountabilities

  • Be accountable for robust biocompatibility evaluation outcomes with technical leadership and sound strategies for successful regulatory submissions.
  • Deliver biocompatibility assessments and biocompatibility evaluation plan and report complying with applicable biological evaluation standards and FDA guidance documents within a risk-based framework.
  • Maintain a knowledge of applicable external standards and regulatory requirements for the biological safety of medical devices and mentor the development of these knowledge in others.
  • Review biocompatibility test results to determine adequacy of data to meet requirements for the biological effects, and utilize problem solving skills and technical knowledge to troubleshoot unexpected results.
  • Manage multiple projects requiring biocompatibility evaluation ensuring timely completion of required tasks to meet project schedules.
  • Collaborate and clearly communicate with internal and external stakeholders (e.g. Contract Research Organizations (CROs)) to ensure appropriate planning and execution of risk assessments and required testing.
  • Support regulatory submissions to global regulatory agencies to elaborate on the product biocompatibility strategy and data in response to additional information requests.
  • Collaborate with Global Supplier Alliance (GSA), engineering teams, and external vendors to procure material specifications and safety data sheets in order to assess safety of products.
  • Participate in design and risk review meetings to address device biological safety concerns and ensure the proper records of biological safety assessments and test plans/reports.
  • Perform gap analysis of external standards, regulatory requirements and guidance associated with biological safety evaluation, and minimize the negative impact of such gaps on the products and business.
  • Provide technical mentoring and training to the broader audience within the organization as required on process and product engineering.

Position Specific Skills and Challenges

  • Extensive knowledge of FDA and ISO 10993 biological safety requirements and test methods including chemical characterization, and Good Laboratory and Good Manufacturing practices (GLP and GMP).
  • Ability to interact at the highest professional manner with all organizational levels.
  • Adaptation of business process to align with industry standards and best practices.
  • Excellent written and verbal communication skills to effectively interact with and contribute constructively to a global team environment internally and externally.
  • Good interpersonal skills and function successfully in a collaborative environment.
  • Planning and organizational skills to prioritize and handle multiple tasks with a sense of appropriate urgency.
  • Attention to detail necessary to maintain the required documentation.
  • Developing technical prowess in self and others.
  • Highly motivated self-starter; be proactive and creative in solving technical problems.
  • Proficiency in Microsoft Office suite (e.g. Word, Excel, PowerPoint, Outlook, OneNote).
  • Must be willing to travel.

Qualifications and Experience

  • 7+ years of industrial/technical work experience in an FDA/ISO regulated environment performing biological safety evaluations and a Bachelor's degree with a discipline in Toxicology, Chemistry, Biochemistry, Biomedical Engineering, Bioengineering, or similar science/engineering discipline, or equivalent combination.
  • A complete understanding and wide application of principle, theories, and concepts in biocompatibility per ISO 10993.
  • Must have prior experience independently developing and driving biocompatibility evaluation strategies with scheduled and defined dependencies between tasks and deliverables for inclusion with worldwide regulatory submissions.
  • Must have prior experience in supporting worldwide market registration.
  • Proven experience with project management skills.