> Markdown version of [/jobs/ext/1893886-principal-design-quality-engineer-cardiac-rhythm-management-diagnostics-crm](https://www.wearedevelopers.com/jobs/ext/1893886-principal-design-quality-engineer-cardiac-rhythm-management-diagnostics-crm). 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 Design Quality Engineer - Cardiac Rhythm Management & Diagnostics (CRM - **Company:** Boston, Inc. - **Location:** Arden Hills, MN, United States - **Experience:** Expert - **Salary:** $102,100.0 - $194,000.0 - **Contract:** Permanent contract - **Skills:** Adobe InDesign, Failure Mode Effects Analysis - **Published:** August 1, 2026 - **Apply:** https://jobs.localjobnetwork.com/apply/add/87901489/1 ## About the Role * Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other related technical discipline). * 9+ yearsof experience in design assurance, new product development or related medical device / regulated industry experience. * Self-motivated with a passion for solving problems and a bias for action. * Strong communication skills (verbal & written). * Demonstrated use of Quality tools/methodologies. * Ability to effectively work and collaborate in a mixed onsite + remote environment. * Demonstrated experience creating detailed technical documents. Preferred qualifications: * Experience working with medical electrical equipment and/or active implantables. * ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis. * Experienced problem solver, capable of facilitating the problem-solving process. * Adaptable and effective collaborator in a team environment or in self-directed work. * Experience with design changes, complaint reduction, and corrective action. ## Description This Principal Design Quality Engineer position will support active implantable medical devices. This position collaborates with cross functional teams including R&D, process development, manufacturing, and regulatory affairs to help ensure that the product and processes remain safe, of high quality, and compliant with BSC and regulatoryrequirements throughout the product lifecycle process., * Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. * Acts as an effective team member in supporting quality disciplines, decisions, and practices. * 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 Design Assurance activities as related to Risk Management, Design Controls, and other DA related priorities. * 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). * Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs). * Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input. * Partner cross-functionally to identify and support value improvement efforts to support business goals. ## Related Videos - [What Production Knows: Closing the Loop Between AI Agents and the Systems They Build](https://www.wearedevelopers.com/videos/100277-what-production-knows-closing-the-loop-between-ai-agents-and-the-systems-they-build) - [What If We Designed Employee Experience Like a Customer Journey?](https://www.wearedevelopers.com/videos/1824-what-if-we-designed-employee-experience-like-a-customer-journey) - [From Bedside Beeps to Interoperable Bytes – Getting your medical devices ready to talk the IEEE 11073 language](https://www.wearedevelopers.com/videos/771-from-bedside-beeps-to-interoperable-bytes-getting-your-medical-devices-ready-to-talk-the-ieee-11073-language) - [Agile work at CARIAD – Creating a customer web application for controlling the vehicle ](https://www.wearedevelopers.com/videos/200-agile-work-at-cariad-creating-a-customer-web-application-for-controlling-the-vehicle) ## Related Articles - [Events like RSAC Get You CISOs. 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