Remote Sterilization Validation Scientist (R&D)

Getinge Group; Fraser (MI); Remote; USD 99.000 - 135.000; Vollzeit

Benefits dieser Stelle

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Wellness initiative & Health Resources

Life Insurance

Short and Long Term Disability

Health & Dependent Care FSA

Parental and Caregiver Leave

Tuition Reimbursement

Zusammenfassung

Getinge is seeking an R&D Sterilization Validation Scientist in Fraser, MI. You will design and validate sterilization programs for medical devices, aligning with global regulatory standards and sustaining engineering needs.

The role emphasizes collaboration across engineering, quality and regulatory teams, with 30–35% travel to Fraser and external labs in support of ANSI/ISO standards, FDA submissions, and lifecycle management.

Qualifikationen

• Extensive knowledge of US/global sterilization standards and validation practices.
• Experience with EO, VHP, steam and related sterilization modalities.
• Strong documentation and regulatory reporting capabilities.

Aufgaben

• Lead sterilization validation activities across NPD and sustaining programs.
• Coordinate with external labs and contract sterilizers for testing and validation.
• Prepare regulatory submissions and technical justifications.

Kenntnisse

Sterilization validation

Regulatory knowledge

Technical writing

Root cause analysis

Cross-functional collaboration

Ausbildung

Bachelor's degree in Microbiology or related

Jobbeschreibung

Getinge is seeking an R&D Sterilization Validation Scientist in Fraser, MI. You will design and validate sterilization programs for medical devices, aligning with global regulatory standards and sustaining engineering needs.

The role emphasizes collaboration across engineering, quality and regulatory teams, with 30–35% travel to Fraser and external labs in support of ANSI/ISO standards, FDA submissions, and lifecycle management.