Principal Software Design Quality Engineer - Cardiac Rhythm Management & Diagnostics

Boston Scientific • Arden Hills, MN

2d • $102,100 - $194,000 • Hybrid

About The Position

This Principal Software Design Quality Engineer position will support active implantable medical devices. This position serves as a leader in design controls, software verification and validation (V&V), risk management, cybersecurity, and regulatory compliance for complex medical devices. In this role, you will partner with cross-functional leaders to influence product and process decisions, guide risk-based approaches, and mentor other engineers to elevate design quality capabilities across the organization.

Requirements

• Bachelor’s degree in engineering, computer science, or related technical discipline and 9+ years of experience in design quality, software quality, new product development or related medical device/regulated industry roles, with a focus on software-intensive products.
• 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.
• Demonstrated ability to lead cross-functional initiatives, influence without direct authority, and make strategic quality decisions.
• Exceptional verbal and written communication skills, with experience presenting to leadership and external regulatory bodies.
• Strong analytical and problem-solving skills, with a record of resolving complex quality issues.

Nice To Haves

• Experience working with medical electrical equipment and/or active implantable devices.
• Comprehensive knowledge of FDA Quality System Regulation (QSR), ISO 13485, ISO 14971, IEC 62304, IEC 82304, and related software standards.
• Background in embedded software, systems engineering, or integration of hardware and software systems.
• Adaptable and effective collaborator in a team environment or in self-directed work.
• Experience with design changes, complaint reduction, and corrective action.
• Experience in code review practices and secure coding principles.
• Experience working with medical equipment comprised of several devices (e.g., active implantable, programmer, mobile monitor, and remote monitoring web-based digital platform).

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.
• Develop and maintain software risk management tools (Hazard Analysis, FMEAs) with traceability to requirements, design, and test artifacts.
• Collaborate with cybersecurity teams to ensure compliance with evolving security requirements and integrate security risk management into the product lifecycle.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Work within a cross-functional team to identify and implement effective controls for new technology in complex medical devices.
• Write various technical documentation for procedure execution, technical rationale, and evidence of the development process.
• Support Post Market activities, as necessary, of risk based on post-market signals.
• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
• Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements.
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Benefits

• Relocation assistance is not available for this position.
• Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal