Microbiologist (Medtech)

TL;DR

Microbiologist (Medtech): Managing sterilization validations and environmental monitoring for medical devices with an accent on FDA/ISO compliance and technical reporting. Focus on performing sterilization validations (gamma, VHP, H2O2), monitoring cleanroom environments, and supporting product development for new implants.

Location: Austin, TX, USA (Onsite)

Company

hirify.global is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions for orthopedics and beyond.

What you will do

• Perform sterilization validations (gamma, VHP and H2O2 gas plasma) and processing of reusable devices.
• Generate protocols, coordinate with test labs, and author technical reports.
• Manage the dose audit program and annual sterilizer requalification.
• Perform routine monitoring of water systems, ISO Class 7 cleanroom environments, and product bioburden.
• Interpret microbiological cultures, sterility tests, chemical characterization, and cytotoxicity testing.
• Ensure compliance with FDA and ISO standards and assist in regulatory submissions.

Requirements

• Bachelor’s degree in microbiology or biology.
• 1+ years of relevant experience.
• Background in Medical Device or other highly regulated industry required.
• Knowledge of technical writing quality and best practices.
• Proficiency in Microsoft Office Suite.

Nice to have

• Knowledge of ISO 13485.

Culture & Benefits

• Comprehensive health coverage: Medical, Dental, and Vision insurance.
• Financial security: 401(k) plan and spending/savings accounts.
• Work-life balance: Paid vacation, sick leave, and holidays.
• Additional perks: Income protection plans, discounted insurance rates, and legal services.