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Boston Scientific · 3 weeks ago

Senior Scientist, Sterility Assurance

Maple Grove, MN

Full-time

Hybrid

Mid, Senior Level

$83K/yr - $157K/yr

2+ years exp

Boston Scientific is seeking a Senior Sterility Assurance Scientist to support core sterility assurance activities within the Global Sterility Assurance team. In this role, you will provide technical support to product development, manufacturing, and contamination control programs while collaborating with cross-functional partners to implement sterilization solutions and maintain compliance with regulatory requirements.

Health CareMedicalMedical Device

No H1B

Responsibilities

Support sterility assurance activities for product development, manufacturing processes, and contamination control programs

Assist in evaluating sterilization modality options and contribute to product validation activities, including documentation and data review

Help implement contamination control and aseptic best practices across manufacturing and R&D areas

Collaborate with R&D, Quality, Regulatory, and Operations teams to ensure sterility assurance requirements are understood and incorporated into project activities

Participate in internal audits, regulatory inspections, and risk assessments by preparing data, documentation, and technical rationale

Apply foundational knowledge of terminal sterilization methods (EO, gamma, moist heat) to support troubleshooting and product development needs

Contribute to project teams by providing sterility assurance input and ensuring requirements are addressed throughout development

Support Global Sterility Assurance network projects and priorities

Qualification

Sterility assuranceTerminal sterilization methodsMicrobiological testing principlesISO 13485 Quality SystemRegulatory complianceCommunication skillsCollaboration skills