Senior Microbiologist - 28074BR - EN in San Jose, CA at Stryker Corporation

Date Posted: 2/6/2018

Job Snapshot

Job Description

  • Advise on microorganisms as they relate to the cleaning, disinfection and sterilization of reusable medical devices.
  • Advise on microorganisms as they relate to the terminal sterilization of single use medical devices.
  • Advise on the biocompatibility of products using industry guidelines and advanced testing technologies.
  • Work closely with R&D teams to develop new products and lead continuous quality improvement initiatives.
  • Apply ISO, FDA and other applicable guidelines to the biological analysis of medical instrumentation and surgical products.
  • Actively support and advise on new product development activities with minimal support.
  • Lead and participate in the development and improvement of processes for existing and new products with minimal support.
  • Support the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ) for terminally sterilized products
  • Review/approve nonconforming material and system documentation
  • Coordinate and complete projects with minimal supervision.
  • Act as mentor to other team members
  • Conduct training for new microbiology team members and external departments.
  • Support and advise regulatory teams on the review and writing of 510(k) submissions
  • Participate in internal regulatory audits (FDA, notified body) as needed
  • Independently conduct external supplier audits of supplier clean rooms and sterilization processes
  • Maintain and improve internal SOP’s / Work Instructions with respects to newly evolving and changing standards and regulatory environment

Job Requirements

  • Bachelors degree in Microbiology, Biology or related field
  • 4+ years desired of applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
  • Demonstrated knowledge of a variety of microbiological concepts, practices, and procedures.
  • Demonstrated knowledge of sterilization techniques.
  • Demonstrated ability to maximize the biocompatibility of products using industry guidelines and advanced testing technologies.
  • Ability to complete complex tasks using creativity, personal experience and good judgment.
  • Ability to apply ISO, FDA and related guidelines toward the design, manufacturing, development, and launch of innovations that are strategically important to the business.
  • Ability to work cross-functionally with Product Development, Operations and Marketing.
  • Demonstrated ability to solve problems, troubleshoot, and organize priorities.
  • Demonstrated interpersonal communication skills.
  • Be a positive, energetic team player, and an advocate for product excellence and quality.
  • Must be results oriented, a quick learner, and able to respond to the urgent needs of the team ensuring all deadlines are met.
  • Demonstrated ability to technically mentor junior team members
  • Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to lift, carry, etc. Generally involves sitting most of the time.
  • Must be able to review printed material.
  • Must be able to use common office equipment (e.g. PC, telephone, fax machine, etc.).
  • Ability to understand and explain detailed regulatory compliance programs and/or issues.
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
  • Ability to analyze and resolve non-routine regulatory issues using independent judgment.
  • Must be able to observe and correct minute inconsistencies (e.g. in the written word, form usage, etc.).
  • Excellent analytical and writing skills.
  • Effective interpersonal communication skills.
  • Effective organizational skills.
  • Excellent independent judgment skills.
  • Self-motivation.
  • Basic PC skills.