Sr Quality Engineer I - Design

Tandem Diabetes Care•Irvine, CA

2d•$109,000 - $125,000•Hybrid

About The Position

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.

Requirements

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).

Nice To Haves

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.

Responsibilities

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.