Principal Software Design Quality Engineer - Cardiac Rhythm Management & Diagnostics

Onsite Location(s):
Arden Hills, MN, US, 55112

Additional Location(s): N/A

Diversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:
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.

Work Mode:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Relocation Assistance:

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.

Your responsibilities will include:

• 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.

What we’re looking for in you:

Required qualifications:

• 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…