Sterilization Validation Scientist (Remote, USA)

Getinge•Fraser, MI

15d•$99,000 - $135,000•Remote

About The Position

The R&D Sterilization Validation Scientist is an essential technical role within the R&D Science team, responsible for designing, validating, and sustaining the sterilization program for Healthmark-manufactured and distributed medical devices. Reporting directly to the Senior Principal Scientist in the R&D Science department, the role integrates sterilization validation into early product development and provides advanced scientific support for sustaining engineering, material changes, and product lifecycle management. The Scientist ensures designs meet global regulatory standards for sterile barrier integrity, material compatibility, and microbial performance before commercial launch and throughout the product lifecycle. This position is fully remote for US candidates, with a preference for candidates in Eastern Standard Time. It requires approximately 30–35% travel to the Fraser, Michigan site and external testing laboratories. The role may involve extended hours during peak business cycles and work in office, laboratory, and manufacturing environments.

Requirements

Bachelor’s degree in Microbiology, Biomedical Engineering, Materials Science, Biology, or a related scientific or engineering field.
3–5+ years of experience directly focused on medical device sterilization validation.
Direct experience working with sterile barrier systems such as pouches, wraps, or rigid container systems.
In-depth knowledge of US and global standards for terminally sterilized medical devices.
Practical experience with industrial sterilization methods, particularly ethylene oxide (EO), vaporized hydrogen peroxide, and moist heat (steam), as well as working knowledge of gamma or electron-beam irradiation and biocompatibility testing under ISO 10993.
Strong technical understanding of biological indicator and chemical indicator requirements and performance standards, including ISO 11138 and ISO 11140 series.
Training in and adherence to Good Documentation Practices and Good Laboratory Practices.
Familiarity with medical device design controls, including FDA 21 CFR Part 820.30 and ISO 13485.
Collaborative mindset and ability to influence cross-functional teams in Engineering, Operations, Quality, and Regulatory.
Excellent technical writing and documentation skills.
Strong root-cause analysis and structured problem-solving skills.
Ability to travel approximately 30–35%.

Nice To Haves

Master’s degree or Ph.D.

Responsibilities

Serve as the sterilization validation subject matter expert on R&D project teams and embed design-for-sterilization principles into early product development.
Define sterilization requirements, evaluate new material technologies, and assess material compatibility with sterilization modalities including EO, steam, gamma, and VHP.
Author, execute, and review R&D protocols, test methods, and validation reports for sterilization validation and material compatibility.
Design and manage validation programs in compliance with applicable ANSI/AAMI/ISO and sterilization standards.
Coordinate and execute microbial barrier testing, physical integrity testing, and accelerated and real-time shelf-life studies.
Direct and manage medical device sterilization and biocompatibility testing with external laboratories, ensuring compliance with ISO 10993.
Partner with external testing laboratories and contract sterilizers to schedule and oversee protocol execution.
Evaluate how manufacturing process improvements, site transfers, and material supplier changes affect sterilization claims and product integrity.
Lead product adoption and equivalency assessments for design modifications and line extensions within existing sterilization validation frameworks.
Perform periodic revalidation, review annual sterilization data, and maintain Design History Files and Risk Management files.
Lead complaint investigations involving product sterilization compatibility and validation issues.
Draft sterilization sections for FDA 510(k), EU MDR technical documentation, and global regulatory submissions.
Prepare scientific justifications and technical assessments supporting product changes when full revalidation is not required.
Investigate R&D-related non-conformances, out-of-specification laboratory results, and test failures; determine root causes and implement corrective actions.