> Markdown version of [/jobs/ext/2513242-design-assurance-engineer-iii-valencia-technologies-integration](https://www.wearedevelopers.com/jobs/ext/2513242-design-assurance-engineer-iii-valencia-technologies-integration). 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). --- # Design Assurance Engineer III - Valencia Technologies Integration - **Company:** Boston, Inc. - **Location:** Marlborough, MA, United States - **Experience:** Experienced - **Salary:** $82,100.0 - $156,000.0 - **Contract:** Permanent contract - **Skills:** Failure Mode Effects Analysis, Systems Integration - **Published:** August 23, 2026 - **Apply:** https://diversityjobs.com/main/sendform/8/8/28176/1/18044141?backUrl=%2Fcareer%2F18044141%2FDesign-Assurance-Engineer-Iii-Valencia-Technologies-Integration-Massachusetts-Marlborough ## About the Role * Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other related technical discipline) * 3+ 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 * Quality Integration experience * 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 Design Assurance Engineer III position will work on the Valencia Technologies Integration project, specifically supporting product Design Control integration and sustaining efforts. This position ensures that during the integration of products and Design Control quality system processes, the product and processes remain safe, of high quality, and compliant with BSC and regulatoryrequirements., * 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 and support integration of design control related products, records, and processes * Write various technical documentation for procedure execution, technical rationale, and evidence of the development process. * Support Design Assurance activities as related to Risk Management remediation, Design Control Quality System integration, and other DA related integration 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, controlled and implemented appropriately (i.e., EN 13485 / CFR820). * 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) * Support Risk Management planning, updating and maintenance of the product risk documentation (Hazard Analysis, Design FMEA, Task Analysis and Fault Tree Analysis, etc.) in compliance with Boston Scientific or Valencia Technologies procedures and external standards (eg. EN 14971). * 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) - [AI Agents & Agentic AI](https://www.wearedevelopers.com/videos/2017-ai-agents-agentic-ai) - [Valven Atlas: Engineering Intelligence That Delivers](https://www.wearedevelopers.com/videos/1660-valven-atlas-engineering-intelligence-that-delivers) - [Physical AI: The Era of Intelligent Machines](https://www.wearedevelopers.com/videos/100141-physical-ai-the-era-of-intelligent-machines) - [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process) - [Boost Productivity with AI: Figma & Playwright MCP Workflows - Aris Markogiannakis](https://www.wearedevelopers.com/videos/1768-boost-productivity-with-ai-figma-playwright-mcp-workflows-aris-markogiannakis) ## Related Articles - [Events like RSAC Get You CISOs. Developers Decide What Actually Gets Deployed.](https://www.wearedevelopers.com/magazine/693-events-like-rsac-get-you-cisos-developers-decide-what-actually-gets-deployed) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Why Attend a Developer Event in 2026?](https://www.wearedevelopers.com/magazine/688-why-attend-a-developer-event-in-2026) - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [What Makes WeAreDevelopers World Congress Different From Every Other Tech Event?](https://www.wearedevelopers.com/magazine/701-what-makes-wearedevelopers-world-congress-different-from-every-other-tech-event)