Sterilization Validation Scientist; Remote

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Date:
Oct 23, 2026

Location:

Fraser, MI, US

Remote Work: 5 days at home (fully remote)

Salary Range: $99,000-$135,000 per year + 10% STIP

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

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 in Fraser, MI, this position focuses on integrating sterilization validation into the early stages of new product development and providing advanced scientific support for sustaining engineering, material changes, and product lifecycle management. The Scientist ensures that all designs meet global regulatory standards for sterile barrier integrity, material compatibility, and microbial performance before commercial launch and throughout the product’s lifecycle.

This position is fully remote for US candidates, with a preference in Eastern Standard Time. The role will require approximately 30-35% travel to our site in Fraser, MI and external testing labs.

• Serve as the sterilization validation SME on R&D project teams, embedding "design for sterilization" principles into the early phases of healthcare consumable product development.
• Define sterilization requirements, evaluate new material technologies, and assess material compatibility with various sterilization modalities (e.g., EO, Steam, Gamma, VHP).
• Author, execute, and review R&D protocols, test methods, and validation reports specific to sterilization validation and material compatibility.

• Design and manage validation programs in strict compliance with ANSI/AAMI/ISO 11135, 11137, 14937 and 17665 and ISO 11607 (Parts 1 &
  2) and applicable sterilization standards (ISO 11135, ISO 11137, ISO 17665).
• Coordinate and execute microbial barrier testing, physical integrity testing (e.g., tensile, burst, dye penetration), and shelf-life studies (accelerated and real-time aging).
• Direct and manage medical device sterilization and biocompatibility testing with external laboratories (ensuring compliance with ISO 10993 standards for material safety and biological evaluation).
• Partner with external testing laboratories and contract sterilizers to schedule and oversee protocol execution.
• Provide technical support for existing product lines, evaluating the impact of manufacturing process improvements, site transfers, or material supplier changes on product sterilization claims and integrity.
• Lead product adoption and equivalency assessments to incorporate design modifications or line extensions into existing sterilization validation frameworks.
• Perform periodic re-validation, review annual sterilization data, and maintain up-to-date Design History Files (DHF) and Risk Management files.
• Lead complaint investigations for product sterilization compatibility and validation issues

• Draft the sterilization sections for regulatory submissions (FDA 510(k), EU MDR Technical Documentation, global filings).
• Author clearly defensible scientific justifications and technical assessments to…