Sterilization Validation Scientist — Drive Med Tech R&D

Getinge; Fraser (MI); Vor Ort; USD 99.000 - 124.000; Vollzeit

Benefits dieser Stelle

Health Insurance

401k plan with company match

Paid Time Off

Wellness initiative & Health Resources

Life Insurance

Short and Long Term Disability

Flexible Spending Accounts

Commuter Benefits

Parental and Caregiver Leave

Tuition Reimbursement

Zusammenfassung

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.

Qualifikationen

• 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).

Aufgaben

• 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.

Kenntnisse

Sterilization validation

Technical writing

Root-cause analysis

Cross-functional collaboration

Ausbildung

Bachelor's degree in Microbiology

Bachelor's degree in Biomedical Engineering

Master's or Ph.D. is a plus

Tools

EO sterilization

VHP sterilization

Steam sterilization

Gamma irradiation

Jobbeschreibung

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.