Senior Staff Microbiologist in Mahwah, NJ at Stryker Corporation

Date Posted: 11/17/2020

Job Snapshot

Job Description

Who we want
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do

As a Senior Staff Microbiologist, you will 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. This position can be based out of a Stryker location or remote office anywhere in the US.

Responsibilities

  • Apply ISO, FDA and other applicable guidelines to the biological analysis of medical instrumentation and surgical products.
  • Be a trusted leader in supporting and advising on new product development activities with respects to reprocessing
  • Have strong knowledge on materials and design features that may be compatible or problematic with different reprocessing methods.
  • Independently write and review functional specifications for products with respect to reprocessing
  • Lead and participate in the development and improvement of processes for existing and new products
  • Lead 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
  • Leadership skills to potentially manage other microbiologists (grades 9-11)
  • 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 SME for all cleaning, sterilization and biocompatibility related questions
  • Lead 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
  • Review all submitted ECO’s for biocompatibility, cleanability, disinfection and sterilization protocols and reports
  • Participate in industry/ standard events and conferences to help change and influence industry
  • Work cross divisionally to optimize corporate procedures for reprocessing to better align divisions with regards to cleaning, sterilization, disinfection and biocompatibility.
  • Actively trouble shoot and advise external laboratories on validation cleaning failures.
  • Support Business Development projects as needed.

What you need

Basic Qualifications:

  • Bachelor’s Degree is required.
  • 8+ years desired experience in applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.

Preferred Qualifications:

  • Bachelor’s Degree in Microbiology, Biology or science related field.
  • 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.
  • 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.

Work From Home: Remote

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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