Principal Biocompatibility and Sterilization Engineer

3 weeks ago

Campbell, California, United States Imperative Care Full time
Job Title: Principal Biocompatibility and Sterilization Engineer

Imperative Care is seeking a highly skilled Principal Biocompatibility and Sterilization Engineer to join our team. As a subject matter expert, you will establish processes, protocols, and methods to ensure compliance with quality standards and regulatory requirements during the development, manufacture, and distribution of our medical device products.

Key Responsibilities:
  • Develop and execute quality plans to ensure products comply with regulatory and internal quality systems requirements.
  • Provide technical expertise in microbiology, sterilization, and biocompatibility during new product development activities, process modification studies, and failure investigations.
  • Manage relationships with suppliers and testing laboratories, including quality agreements, performance assessments, and corrective action plans.
  • Participate in supplier qualification activities, including on-site audits and evaluations.
  • Develop and implement sterilization protocols and procedures according to regulations.
  • Plan and execute validation studies of sterilization and assessments, and requalification activities.
Requirements:
  • BS in Engineering or similar discipline and 12+ years of relevant experience, or equivalent combination of education and work experience.
  • Master's degree and catheter, endovascular, or neurological device experience or related regulated industry is preferred.
  • Strong knowledge of sterilization (ISO11135), microbiology (ISO 11737 series and ISO 11138 series), cleanrooms (ISO 14644 series, ISO 14698, AAMI TIR 52), biocompatibility (ISO 10993 series), quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), risk management standards (ISO 14971), and good manufacturing practices.
  • Excellent communications skills, with strong ability to review technical documentation and write clear and concise procedures.
Benefits:
  • Competitive salary range: $182,000 - $193,000 annually.
  • Stock options, 401k plan, health benefits, generous PTO, and parental leave program.

Imperative Care is a company that values its employees and offers a comprehensive benefits package. If you are a motivated and experienced professional looking for a new challenge, please consider joining our team.

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