Senior Scientist, Sterility Assurance

About the role:

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 under the guidance of senior team members. You will collaborate with cross‑functional partners to help implement sterilization solutions and maintain compliance with applicable regulatory requirements.

Work model, sponsorship, relocation:

This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer or take over visa sponsorship for this position. Relocation assistance is not available at this time.

Your responsibilities will include:

• 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.

Qualifications

Required:

• Bachelor’s degree in Microbiology, Pharmaceutical Sciences, Biomedical Engineering, or related field (or equivalent experience).
• 2–4 years of experience in sterility assurance, aseptic processing, or sterile product manufacturing.
• Foundational knowledge of terminal sterilization methods (EO, gamma, moist heat) and basic microbiological testing principles.
• Familiarity with relevant global regulatory expectations for sterility assurance (e.g., FDA, ISO, ICH).
• Strong communication and collaboration skills in team‑based environments.
• Experience working in an ISO 13485 Quality System.

Preferred:

• Master’s degree in a scientific or engineering discipline.
• Experience supporting new product development or process changes in a regulated industry.
• Understanding of contamination control practices in medical device or pharmaceutical manufacturing.
• Exposure to audits or regulatory inspections involving sterility assurance topics.

Requisition : 621059

Minimum Salary: $82,600

Maximum Salary: $156,900

Boston Scientific Corporation is an equal opportunity employer. All employment is decided on the basis of qualifications, merit, and business need. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Applicants for this role will be required to provide proof of COVID‑19 vaccination status (if required) and subject themselves to a prohibited substance test because this is a safety‑sensitive position.