To provide strategic leadership and technical expertise supporting capital equipment and software product development within the Interventional Cardiology (IC) division, ensuring compliance with global regulatory requirements and standards, while driving innovation and efficiency across the software development lifecycle (SDLC).
Requirements
- Proven expertise in Software Development Life Cycle (SDLC), risk management, and software verification and validation.
- Extensive experience with software quality tools, issue tracking (e.g., JIRA), and requirements/test management platforms.
- In-depth understanding of software configuration management, version control systems, and related quality controls.
- Comprehensive knowledge of FDA Quality System Regulation (QSR), ISO 13485, ISO 14971, IEC 62304, IEC 82304, and related software standards.
- Experience with global regulatory submissions and interacting with notified bodies or FDA.
Responsibilities
- Serve as the primary software design quality lead for complex and strategic product development initiatives, from concept through commercialization.
- Drive and oversee implementation of risk management processes (ISO 14971), including hazard analysis, software FMEAs, and security risk analysis, ensuring integration into the development process.
- Lead development and execution of comprehensive software V&V strategies to ensure robust, compliance, and efficient testing aligned with IEC 62304 and other applicable standards.
- Provide expert guidance on system and software design controls, leading design reviews, software bug triage, and field issue investigations with a focus on systemic corrective actions.
- Champion the use of data-driven decision-making and advanced problem-solving methodologies to resolve quality issues and mitigate risks.
Other
- Relocation assistance is available for this position.
- Boston Scientific will consider offering sponsorship or take over sponsorship of an employment visa for this position.
- Bachelor’s degree in engineering, computer science, or related technical discipline and 9+ years of experience in design quality, software quality, or related medical device/regulated industry roles, with a focus on software-intensive products.
- Exceptional verbal and written communication skills, with experience presenting to leadership and external regulatory bodies.
