Biological Sciences Analyst – Medical Device Testing

About the role

Applied Medical is seeking a Biological Sciences Analyst to support and coordinate biocompatibility, bioburden, sterility, and other biological testing programs for medical device manufacturing. Working under senior team members, you will help ensure compliance with regulatory requirements and internal quality standards.

Key responsibilities

• Coordinate biological testing activities (bioburden, sterility, biocompatibility) performed by external third‑party laboratories for routine quality and R&D projects.
• Organize and monitor quarterly, semi‑annual, and ad‑hoc laboratory audits, ensuring timely completion.
• Prepare, review, and maintain testing protocols, study plans, and final laboratory reports in line with quality and regulatory guidelines.
• Analyze laboratory data, identify trends, and support investigations into test results and performance metrics.
• Manage purchase requisitions and orders related to testing activities.

Required profile

• Strong analytical skills with high attention to detail.
• Ability to collaborate effectively within a multidisciplinary team.
• Commitment to continuous improvement and delivery of high‑quality results.
• Willingness to stay current with evolving regulations and industry standards.

Required skills

• Biocompatibility testing
• Sterility testing
• Bioburden testing
• Laboratory data analysis
• Knowledge of regulatory standards (e.g., ISO 10993, FDA)