Sterilization Validation Scientist (Fraser, MI)

Job Overview

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.

Job Responsibilities and Essential Duties:

1. New Product Development (NPD) Support

• 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.

2. Sterilization Validation & Integrity Testing

• 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.

3. Sustaining Engineering & Existing Product Support

• 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

4. Technical Writing & Regulatory Compliance

• 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 support product changes without requiring full re-validation where appropriate.
• Investigate R&D-related non-conformances, out-of-specification (OOS) lab results, or test failures, determining root causes and implementing corrective actions.

Required Knowledge, Skills and Abilities:

• 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), plus working knowledge of Gamma/E-beam irradiation, and biocompatibility testing (ISO 10993).
• Strong technical understanding of biological indicator (BI) and chemical indicator (CI) requirements and performance standards (e.g., ISO 11138 and ISO 11140 series).
• Prior training and adherence to Good Documentation Practices and Good Laboratory Practices
• Familiarity with medical device design controls (FDA 21 CFR Part 820.30 and ISO 13485).

• Strong collaborative mindset with the ability to influence cross-functional project teams (Engineering, Operations, Quality, Regulatory).
• Excellent technical writing and documentation skills.
• Strong root-cause analysis and structured problem-solving skills.

Minimum Requirements:

• Bachelor’s degree in Microbiology, Biomedical Engineering, Materials Science, Biology, or a related scientific/engineering field (Master’s or Ph.D. is a plus).
• 3–5+ years of experience directly focused on medical device sterilization validation.
• Direct experience working with sterile barrier systems (pouches, wraps, or rigid container systems).

Environmental/Safety/Physical Work Conditions: 

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Works in office, laboratory, and manufacturing environments; follows applicable safety procedures and personal protective equipment (PPE) requirements when in the laboratory or on the production floor.
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
• May work extended hours during peak business cycles.
• The position requires travel of approximately 5-10%.
• Able to lift 20 lbs. and stand for longer periods of time.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.