> Markdown version of [/jobs/ext/572386-sr-quality-engineer-i-hardware](https://www.wearedevelopers.com/jobs/ext/572386-sr-quality-engineer-i-hardware). 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). --- # Sr Quality Engineer I - Hardware - **Company:** Tandem Diabetes Care - **Location:** Irvine, CA, United States (Remote available) - **Experience:** Expert - **Salary:** $109,000.0 - $125,000.0 - **Contract:** Permanent contract - **Skills:** Failure Mode Effects Analysis, Reliability Engineering, Software Reliability Testing, Software Systems, Strategies of Testing - **Published:** June 20, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=a0958f267ebb7e0d ## About the Role Do you have experience in Sterilization?, * Bachelor's degree in a technical field, preferably Mechanical or Biomedical Engineering or the equivalent education and applicable work experience. * 5+ years of experience working as a Quality Engineer in an FDA-regulated industry within design and development (equivalent experience will be considered). * Advanced understanding of Risk Management per ISO 14971, including hazard analysis, FMEA, risk control implementation, residual risk evaluation, and lifecycle maintenance of risk management files. * Applies statistical and analytical techniques, including sampling theory, probability, capability analysis, test method validation, and measurement system analysis to evaluate design margins, characterize variability, inform tolerance decisions, and define risk-based verification strategies. * In-depth knowledge of FDA Quality System Regulation (21 CFR Part 820) with demonstrated application of Design Controls (820.30) for regulated medical devices. * Familiarity with design transfer requirements, including considerations for manufacturability, testability, and contract manufacturing. * Working knowledge of terminal sterilization modalities and sterile packaging systems, including gamma radiation, e-beam, and ethylene oxide (EtO), with the ability to assess design-related risks (e.g., functional degradation, shelf life, and sterility assurance). * Understanding of electro-mechanical and software systems (hardware, software, control algorithms), consumables, and packaging within a regulated design environment. * Working knowledge of mechanical drawings and specifications, including interpretation of geometric dimensioning and tolerancing (GD&T). * Familiarity with common medical device manufacturing and assembly technologies (e.g., molding, electronic assembly, surface-mount technology, joining and bonding methods, forming and machining operations, and product identification processes) is desirable, with the ability to understand how manufacturing capabilities and limitations may influence mechanical design decisions, tolerances, and risk controls; deep hands-on manufacturing expertise is not required., Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information., Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. ## Description The Senior Design Quality Engineer plays a critical role in ensuring the design, development, commercialization, and lifecycle management of regulated medical devices meet the highest standards of regulatory compliance, design quality, reliability, and patient safety. As a key Quality leader partnering closely with R&D, Regulatory Affairs, Clinical, Manufacturing, and Supplier Quality teams, this role provides quality leadership across the full product lifecycle, from concept and product launch through sustaining engineering and post-market support. The position drives robust Design Controls and Risk Management practices for complex electro-mechanical systems and consumables, while working independently to optimize and continuously improve quality system processes and internal operations to ensure conformance to specifications, effective risk reduction, and continuous improvement of both device quality and business performance. Sr. Design QEs at Tandem are also responsible for: * Serves as the Design Quality representative on new product development and sustaining engineering projects, providing quality leadership throughout the design and development lifecycle. This includes oversight and approval of design verification and validation activities such as test strategies, protocols, reports, reliability testing, and compliance with the Quality Management System. * Leads and ensures execution of Design Controls in compliance with 21 CFR 820.30, ISO 13485, and applicable global regulations, including planning, documentation, and maintenance of the Design History File (DHF). * Ensures traceability between user needs, design inputs, design outputs, risks, verification, and validation activities, and confirms that residual risks are acceptable and documented. * Drives and supports risk management activities in accordance with ISO 14971, including hazard analysis, FMEA, implementation of risk controls, and maintenance of risk management files across the product lifecycle. * Independently applies and executes modern design quality engineering tools and methodologies including risk-based analysis (ISO 14971), advanced statistical techniques (e.g., design margin and sensitivity analysis, process capability assessment), design of experiments, measurement system analysis, and reliability engineering. * In partnership with the Risk Management team, use post-market data, complaint trends, and failure investigations to inform design improvements, risk reassessments, and verification strategy updates. * Ensures compliance with company policies, including Privacy/HIPAA, and all applicable regulatory, legal, and safety requirements., Hybrid: This role will be a mix of in-office work at our Irvine Office and remote work. This position is expected to be in office 2-3 days per week but may vary depending on business demands. ## Related Videos - [Rethinking Intelligence: AI, Accessibility, and the Future of Inclusive Work - Artur Ortega](https://www.wearedevelopers.com/videos/1377-rethinking-intelligence-ai-accessibility-and-the-future-of-inclusive-work-artur-ortega) - [Your Testing Strategy is broken - lets fix it!](https://www.wearedevelopers.com/videos/1672-your-testing-strategy-is-broken-lets-fix-it) - [Staying Safe in the AI Future](https://www.wearedevelopers.com/videos/521-staying-safe-in-the-ai-future) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [The Algorithm That Nearly Killed Me: When Testing Isn't Enough](https://www.wearedevelopers.com/videos/2110-the-algorithm-that-nearly-killed-me-when-testing-isn-t-enough) - [How to TDD in legacy code](https://www.wearedevelopers.com/videos/309-how-to-tdd-in-legacy-code) ## Related Articles - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Now is the time for industrialized software development](https://www.wearedevelopers.com/magazine/601-now-is-the-time-for-industrialized-software-development) - [Where to Find Entry-Level Software Engineering Jobs](https://www.wearedevelopers.com/magazine/397-where-to-find-entry-level-software-engineering-jobs) - [Is Software Engineering Over-Saturated?](https://www.wearedevelopers.com/magazine/418-is-software-engineering-over-saturated) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [The 8 Best Code Testing Tools](https://www.wearedevelopers.com/magazine/402-the-8-best-code-testing-tools)