Boston Scientific Product Assurance Engineer II 

United States, California, Irvine 

783544556

Your responsibilities will include:

• Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on multiple and moderately complex processes. Represent the Product Assurance function within cross-functional product development teams, ensuring quality assurance, usability, and regulatory compliance throughout the product lifecycle.
• Contribute to software verification and validation by supporting the development of test strategies, applying relevant statistical techniques, and executing structured testing procedures.
• Design, develop, and execute test cases and test methods to verify system functionality and ensure business and user requirements are met; document results and author detailed test reports.
• Develop and maintain software development lifecycle (SDLC) documentation, traceability matrices, and design records to support regulatory submissions and internal quality management systems.
• Establish, implement, and maintain quality systems in accordance with FDA regulations, ISO 13485, IEC 62304, and other applicable international standards.
• Assist in internal and external audits to evaluate GMP and ISO compliance, support the identification of risks—including cybersecurity vulnerabilities, and contribute to recommending corrective actions that uphold product integrity and regulatory readiness.
• Collaborate closely with software development, hardware engineering, and other cross-functional teams; actively participate in scrum meetings, product reviews, and bug triage sessions.
• Possess strong knowledge of comprehensive risk management documentation, including Hazard Analysis, Task Analysis, and Design FMEAs, with familiarity in applying advanced risk mitigation strategies.
• Participate in design verification, validation, and usability testing activities, contributing to alignment with internal and external requirements.
• Support junior engineers by sharing technical insights related to product assurance, regulatory compliance, and software quality practices.
• Contribute to continuous improvement efforts by helping identify process gaps, refine tools and documentation, and promote quality-focused practices.

Required qualifications:

• Bachelor’s degree in Engineering, Science, or a related technical field
• Minimum of 2 years of experience in a Quality Assurance role, preferably within a regulated industry

Preferred qualifications:

• Medical device industry experience

Maximum Salary: $ 138300

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.