Remote Sterilization Validation Scientist

Getinge; Oregon; Hybrid; USD 99,000 - 135,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Tuition Reimbursement

Parental and Caregiver Leave

Commuter Benefits

Job summary

Getinge is seeking an R&D Sterilization Validation Scientist to lead the design, validation, and sustaining of sterilization programs for healthcare devices. This role collaborates with the R&D Science team in Fraser, MI and supports early product development with sterilization considerations.

The position is remote for US candidates with 30-35% travel to Fraser, MI and requires expertise in ANSI/AAMI/ISO standards, ISO 10993, and regulatory writing.

Qualifications

• Bachelor’s degree in Microbiology, Biomedical Engineering, Materials Science, Biology, or a related scientific/engineering field.
• 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 into the early phases of healthcare consumable product development. Define sterilization requirements, evaluate new material technologies, and assess material compatibility with various sterilization modalities (EO, Steam, Gamma, VHP).
• Design and manage validation programs in strict compliance with ANSI/AAMI/ISO 11135, 11137, 14937 and 17665 and ISO 11607; coordinate microbial barrier testing, physical integrity testing, and shelf-life studies; manage external laboratories and contract sterilizers.
• Provide technical support for existing product lines, leading re-validation, maintenance of DHF and Risk Management files, and lead complaint investigations for sterilization compatibility and validation issues.
• Draft sterilization sections for regulatory submissions (FDA 510(k), EU MDR Technical Documentation) and investigate non-conformances to determine root causes and corrective actions.

Skills

Sterilization standards

EO/VHP/Steam sterilization

Biocompatibility testing ISO 10993

Good Documentation Practices

FDA 21 CFR Part 820.30 / ISO 13485

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in Microbiology/Biomedical Engineering/Materials Science/related

Master’s or Ph.D. is a plus

Job description

Getinge is seeking an R&D Sterilization Validation Scientist to lead the design, validation, and sustaining of sterilization programs for healthcare devices. This role collaborates with the R&D Science team in Fraser, MI and supports early product development with sterilization considerations.

The position is remote for US candidates with 30-35% travel to Fraser, MI and requires expertise in ANSI/AAMI/ISO standards, ISO 10993, and regulatory writing.