Remote Sterilization Validation Scientist for Med Devices

Getinge; Fraser (MI); Remote; USD 99,000 - 135,000; Full time

Benefits offered by this job

Health insurance

401k plan with company match

Paid Time Off

Tuition Reimbursement

Job summary

Getinge is seeking an experienced R&D Sterilization Validation Scientist to design, validate, and sustain sterilization programs for healthcare devices. Remote work is available for U.S. candidates, with travel to Fraser, MI about 30–35%.

You will integrate sterilization into early product development and support sustaining engineering and lifecycle management. The role requires 3–5+ years in medical device sterilization validation, expertise in EO/Steam/Gamma, and strong technical writing and

Qualifications

• Bachelor’s degree or higher in a related scientific or engineering field.
• 3–5+ years directly focused on medical device sterilization validation.
• Experience with sterile barrier systems (pouches, wraps, or rigid containers).

Responsibilities

• Serve as sterilization validation SME on R&D project teams.
• Define sterilization requirements and assess material compatibility.
• Draft and review validation protocols and reports.
• Coordinate microbial barrier and physical integrity testing.
• Lead re-validation and lifecycle maintenance for products.

Skills

Sterilization validation

Biocompatibility testing

Regulatory compliance

Technical writing

Root-cause analysis

Education

Bachelor’s degree in Microbiology or related field

Tools

EO/Steam/Gamma sterilization

ISO/ANSI standards

Job description

Getinge is seeking an experienced R&D Sterilization Validation Scientist to design, validate, and sustain sterilization programs for healthcare devices. Remote work is available for U.S. candidates, with travel to Fraser, MI about 30–35%.

You will integrate sterilization into early product development and support sustaining engineering and lifecycle management. The role requires 3–5+ years in medical device sterilization validation, expertise in EO/Steam/Gamma, and strong technical writing and