Sterilization Validation Scientist (Fraser, MI)
Getinge
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Benefits offered by this job
Job summary
Getinge in Fraser, MI invites an experienced R&D Sterilization Validation Scientist to design, validate, and sustain the sterilization program for Healthmark medical devices. You will integrate sterilization validation into early product development and provide advanced scientific support for sustaining engineering.
Responsibilities include leading validation programs per ANSI/AAMI/ISO standards, coordinating microbial and physical testing, and collaborating with external labs.
Qualifications
- Bachelor's degree in Microbiology, Biomedical Engineering, Materials Science, Biology, or a related 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).
Responsibilities
- Serve as the sterilization validation SME on R&D project teams, embedding 'design for sterilization' principles into development.
- Define sterilization requirements, evaluate materials, and assess compatibility with EO, Steam, Gamma, and VHP.
- Author, execute, and review R&D protocols, test methods, and validation reports for sterilization and material compatibility.
- Design and manage validation programs per ANSI/AAMI/ISO standards and ISO 11607; coordinate microbial barrier testing.
- Lead sustaining engineering activities, DHF updates, and risk management for sterilization claims.
- Draft regulatory submissions sections and investigate non-conformances with root-cause analyses.
Skills
Education
Tools
Job description
With a passion for life
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.
- 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 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.
- 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.
- 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).
- 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.
The salary range for this position is between $99,000-$124,000 per year depending on experience, + 10% STIP
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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