Senior EtO Sterilization Process Engineer

Boston Scientific; Coventry (RI); Vor Ort; USD 89.000 - 170.000; Vollzeit

Zusammenfassung

Boston Scientific is seeking a Senior Sterilization Engineer to provide advanced technical leadership in EtO sterilization across the global organization. You will independently drive sterilization process development, validation, investigations and cross-functional collaboration to improve quality and compliance.

The role requires mentoring peers, guiding audits, and ensuring patient safety through robust technical solutions.

Qualifikationen

• Bachelor's degree in engineering or related technical field.
• Minimum of 5 years' experience in sterilization engineering, manufacturing engineering or related technical field.
• Experience leading technical projects, investigations, or validation activities.

Aufgaben

• Provide advanced technical leadership for sterilization operations.
• Lead investigations of significant nonconformances and develop robust solutions.
• Lead development and validation strategies, protocols and reports for EtO sterilization.
• Drive continuous improvement, process capability, quality, efficiency and regulatory compliance.
• Mentor engineers and cross-functional partners in sterilization engineering principles.
• Interpret FDA, ISO and other regulatory requirements for sustained compliance.

Kenntnisse

Sterilization engineering

EtO sterilization

Process validation

Statistical analysis

Root cause investigation

Cross-functional leadership

Regulatory compliance

Technical mentorship

Quality systems

Ausbildung

Bachelor's degree in engineering

Jobbeschreibung

Boston Scientific is seeking a Senior Sterilization Engineer to provide advanced technical leadership in EtO sterilization across the global organization. You will independently drive sterilization process development, validation, investigations and cross-functional collaboration to improve quality and compliance.

The role requires mentoring peers, guiding audits, and ensuring patient safety through robust technical solutions.