Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.
Position Description
The Microbiologist supports microbiological testing and sterility assurance activities within Applied Medical's Biological Sciences Department. This role provides technical expertise in microbiological testing, validation, contamination control, and regulatory compliance for sterile medical devices while collaborating with Quality, Regulatory Affairs, R&D, and external testing laboratories.
Key Responsibilities
- Oversee microbiological testing activities, including bioburden testing, microbial identification, environmental monitoring, sterility testing, endotoxin testing, and contamination control.
- Troubleshoot testing workflows and recommend improvements that enhance efficiency, compliance, and data quality.
- Ensure testing activities are conducted in accordance with laboratory procedures, FDA regulations, and applicable ISO and USP standards.
- Guide and train Associate Microbiologists and Laboratory Technicians.
- Support internal audits, supplier audits, and FDA inspections by providing microbiological expertise and technical support.
- Participate in microbiological investigations, root cause analyses, contamination control initiatives, and CAPA activities.
- Support microbiological evaluations associated with sterile medical device development, sterilization validation, packaging validation, and ongoing product monitoring.
- Review microbiological test strategies, study results, and validation activities to ensure scientific rigor and regulatory compliance.
- Serve as a subject matter expert on microbiological testing, sterility assurance, contamination control, and microbiological risk assessment.
Success in This Role
- Scientific assessments and microbiological recommendations support compliant and effective business decisions.
- Technical expertise contributes to successful product development, validation, and lifecycle management of sterile medical devices.
- Regulatory inspections and audits are supported confidently and successfully.
- Junior team members are effectively trained and supported.
- Cross-functional teams view the Microbiologist as a trusted microbiology and sterility assurance expert.
- Scientific expertise drives effective investigations, risk assessments, and resolution of microbiological quality issues.
Position Requirements
This position requires the following skills and attributes:
- Bachelor's degree in Microbiology or related life science discipline (Microbiology preferred).
- 3-7 years of experience in microbiology testing laboratories supporting medical devices, pharmaceuticals, biologics, or contract testing services.
- Hands-on experience with microbial identification, culture-based methods, gram staining, microbial characterization, and aseptic laboratory techniques.
- Experience supporting microbiological testing and validation of sterile medical devices.
- Experience performing and interpreting bioburden assessments, recovery studies, and contamination investigations.
- Experience supporting FDA inspections and quality system audits.
- Knowledge of sterility assurance principles and microbiological risk assessment.
- Working knowledge of ISO/IEC 17025, FDA quality system requirements, and laboratory quality systems.
- Working knowledge of microbiological standards applicable to sterile medical devices, including:
- ISO 11737-1 (Bioburden Determination)
- ISO 11737-2 (Sterility Testing)
- Applicable sterilization validation standards
- Familiarity with:
- USP <71> Sterility Tests
- USP <85> Bacterial Endotoxins Test
- USP <61> and <62> Microbiological Examination
- Experience with environmental monitoring, contamination control, and good laboratory practices.
- Strong technical writing, analytical, troubleshooting, and communication skills.
- Proficiency in Microsoft Office and electronic quality or laboratory management systems.
Preferred
The following skills and attributes are preferred:
- Master's degree in Microbiology or related scientific discipline.
- Experience in the medical device industry and sterile product development.
- Experience supporting FDA, ISO, Notified Body, and customer audits.
- Experience executing microbiological validation protocols and authoring technical reports.
- Experience with microbiological risk assessments, investigations, CAPA activities, and contamination control programs.
- Experience managing external microbiology testing laboratories.
- Experience with bioburden recovery method development, recovery efficiency studies, sterilization validation, and microbiological evaluations performed in accordance with ISO 11737 standards.
- Knowledge of ethylene oxide, radiation, or other terminal sterilization processes.
Benefits
- Competitive compensation range: $71000 - $80000 / year (California).
- Comprehensive benefits package.
- Training and mentorship opportunities.
- On-campus wellness activities.
- Education reimbursement program.
- 401(k) program with discretionary employer match.
- Generous vacation accrual and paid holiday schedule.
Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.
Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.
All compensation and benefits are subject to plan documents and written agreements.
Equal Opportunity Employer
Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.