> Markdown version of [/jobs/ext/3735316-principal-software-design-quality-engineer-cardiac-rhythm-management-diagnostics](https://www.wearedevelopers.com/jobs/ext/3735316-principal-software-design-quality-engineer-cardiac-rhythm-management-diagnostics). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md).

---

# Principal Software Design Quality Engineer - Cardiac Rhythm Management & Diagnostics

- **Company:** Boston, Inc.
- **Location:** Arden Hills, MN, United States
- **Experience:** Expert
- **Salary:** $102,100.0 - $194,000.0
- **Contract:** Permanent contract
- **Skills:** Adobe InDesign, Systems Engineering, JIRA, Software Quality, Code Review, Cyber Security, Embedded Software, Failure Mode Effects Analysis, Issue Tracking Systems, Secure Coding, Software Configuration Management, Software Engineering, Software Systems, Test Management, Software Verification, Information Technology, Software Version Control
- **Published:** October 14, 2026
- **Apply:** https://diversityjobs.com/career/18629370/Principal-Software-Design-Quality-Engineer-Cardiac-Rhythm-Management-Diagnostics-Minnesota-Arden-Hills

## About the Role

* 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.

Preferred qualifications:

 * 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).

## Description

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., * 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 regulatoryrequirements and internal standards.
 * Support the verification, validation, and usability testing to meet or exceed internal and externalrequirements.
 * 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.