- Provide support to the validation department in regards to decisions on what systems require validation as well as support the validation/remediation of software installed in the company, maintain the change control of the software and provide guidance in IQ creation and execution.
- Identify areas that may require software validation and advice system owners about validation requirements.
- Analyze areas for improvement and recommend/advice about software solutions.
- Maintain procedures related to Software Validation.
- Support project transfer teams on Equipment Software Qualification and other non-device software validation activities to ensure compliance requirements are met.
- Participate in Equipment Qualification Strategy and Planning meetings.
- Support qualification deliverables review and approval activities.
- Partner with cross-functional stakeholders to ensure successful software validation and compliance execution.
- Support software-related quality processes including change control, risk management, NCEP, and CAPA activities.
- Minimum Bachelor’s Degree in Engineering discipline or related field of study or related technical field.
- ASQ Certified Software Quality Engineering Certification (CSQE) or related professional certifications are valued.
- 3-4 years' experience in Quality, QA or related medical device experience.
- Working knowledge of Medical Device Quality Management System.
- Knowledgeable in Quality System Regulations, Medical Device Regulations, ISO 13485 Quality Standards, FDA 21 CFR Part 820 and FDA 21 CFR Part 11.
- Serves as Software QA representative for Software Control Projects, NPI as well as sustaining efforts.
- Support other Software Quality related processes such as non-device software related NCEP/CAPA and risk management.
- Work with cross-functional teams to resolve quality issues related to software.
- Software QA experience within a regulated environment.
- Strong attention to detail with the ability to think critically.
- Ability to work proactively and independently.
- Ability to manage multiple priorities and work efficiently in a fast-paced environment.
- Knowledge of software validation lifecycle, change control, and computerized system validation.
- Strong documentation, problem-solving, and communication skills.
- Experience with Equipment Software Qualification and Validation activities.
- Qualification protocol review and approval experience.
- Stakeholder management and cross-functional collaboration skills.
About Us
As a global medical technology leader for more than 45 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Skills Required
- Bachelor's degree in Engineering or related technical field
- 3-4 years' experience in Quality, QA, or related medical device experience
- Working knowledge of Medical Device Quality Management System (QMS)
- Knowledge of Quality System Regulations, ISO 13485, FDA 21 CFR Part 820 and Part 11
- ASQ Certified Software Quality Engineering (CSQE) or related certification
- Experience with software validation lifecycle, change control, and computerized system validation
- Experience with Equipment Software Qualification and validation activities (IQ creation/execution)
- Serve as Software QA representative for Software Control Projects, NPI and sustaining efforts
- Support non-device software quality processes including NCEP, CAPA, and risk management
- Qualification protocol review and approval experience
- Strong documentation, problem-solving, communication, and stakeholder management skills
- Ability to work proactively, independently, manage multiple priorities in a fast-paced environment
- Software QA experience within a regulated environment and cross-functional collaboration to resolve quality issues
Boston Scientific Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Boston Scientific and has not been reviewed or approved by Boston Scientific.
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Healthcare Strength — Healthcare coverage is positioned as comprehensive, spanning medical, dental, vision, life, and disability insurance alongside mental health resources. Family planning support and broader care navigation offerings further strengthen the health-related value of the package.
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Retirement Support — Retirement benefits stand out through a 401(k) match described as best-in-class and supported by profit sharing and an employee stock purchase plan. High participation in retirement programs is also highlighted as part of the overall financial benefits footprint.
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Leave & Time Off Breadth — Time off is described as generous, with reports of 20+ vacation days and up to four weeks in some roles, plus paid holidays and sick leave. Longer-term options such as extended unpaid family leave and a personal enrichment sabbatical expand flexibility beyond standard PTO.
Boston Scientific Insights
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What We Do
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. For more information, visit www.bostonscientific.com and connect with us on X, Instagram, and Facebook. At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers. You may also review our social media guidelines at http://www.bostonscientific.com/social.
