job description
Join Boston Scientific, a global leader in medical technology, as an Equipment Software Quality Engineer II in beautiful Bali, Indonesia. In this pivotal role, you will ensure the highest standards of software quality for medical equipment, supporting project transfer teams in Equipment Software Qualification and non-device software validation to guarantee compliance with industry regulations and internal quality systems.
As part of our dynamic team, you will collaborate with cross-functional stakeholders to drive continuous improvement in software validation processes, mitigate risks, and contribute to the development of life-changing medical solutions. This is a unique opportunity to combine technical expertise with a passion for healthcare innovation in a tropical, work-life balanced environment.
If you are a detail-oriented professional with a strong background in software quality assurance and a commitment to excellence, we invite you to apply and help us advance patient care through cutting-edge technology.
Responsibility
- Lead and support Equipment Software Qualification (ESQ) activities for medical device manufacturing and testing equipment.
- Develop, review, and execute software validation protocols and reports in compliance with FDA 21 CFR Part 11, ISO 13485, and other relevant standards.
- Collaborate with project transfer teams to ensure seamless transition of software systems with validated performance.
- Identify, assess, and document software-related risks and implement mitigation strategies.
- Conduct audits and gap analyses of existing software systems to ensure adherence to quality standards.
- Provide technical guidance to engineering teams on software quality best practices and regulatory requirements.
- Maintain and update software validation documentation for traceability and compliance.
- Participate in cross-functional reviews to ensure software changes are properly validated before implementation.
Qualifications
- Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, or a related field. Advanced degree preferred.
- Minimum 5 years of experience in software quality assurance, validation, or a similar role, preferably in the medical device or regulated industry.
- In-depth knowledge of software validation standards (e.g., FDA 21 CFR Part 11, IEC 62304, ISO 13485).
- Experience with Equipment Software Qualification (ESQ) and non-device software validation processes.
- Strong understanding of risk management (ISO 14971) and quality management systems.
- Proficiency in requirements management tools (e.g., DOORS, Jama) and test automation frameworks.
- Excellent analytical, problem-solving, and communication skills with the ability to work in a global team.
- Familiarity with Agile/Scrum methodologies is a plus.