Sr Quality Engineer I (Hardware)

Tandem Diabetes Care

1d•$108,000 - $120,000•Hybrid

About The Position

GROW WITH US: Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry. STAY AWESOME: Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com A DAY IN THE LIFE: 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. A Senior Design Quality Engineer at Tandem also: 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. Reviews and approves new designs, design changes, design-related change orders, ensuring that design inputs, outputs, verification, validation, design reviews are appropriately defined, executed, and documented. 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. Supports and participates in internal and external audits, including FDA and notified body inspections, with a focus on design controls, risk management, and product lifecycle compliance. Ensures compliance with company policies, including Privacy/HIPAA, and all applicable regulatory, legal, and safety requirements.

Requirements

Bachelor’s degree in a technical field, preferably Mechanical Engineering or the equivalent education and applicable work experience.
5 plus years’ experience working as a Quality Engineer in an FDA-regulated hardware development environment, medical device development, or an FDA-regulated industry.
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.
Strong working knowledge of ISO 13485 and global design control expectations throughout the product lifecycle.
Knowledge of design verification and validation (V&V) principles, including risk‑based test strategy development, reliability testing, and compliance documentation for regulatory submissions.
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.
Knowledge of post‑market quality systems, including complaint handling, failure investigation, CAPA, and their feedback to design controls and risk management.
Working knowledge of mechanical drawings and specifications, including interpretation of geometric dimensioning and tolerancing (GD&T).
Strong written and verbal communication skills, with the ability to consolidate, evaluate, and present technical quality information clearly to cross‑functional teams, management, and external auditors.

Nice To Haves

Experience in a ISO environment preferred.
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.
General understanding of supplier quality within a design controls framework, including how supplier capabilities, specifications, and risk controls interface with design verification and validation, with experience collaborating with Supplier Quality teams during development and sustaining activities.
Understanding of regulatory inspection and technical review expectations for FDA audits and Notified Body assessments, particularly related to design documentation and risk management.

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.
Reviews and approves new designs, design changes, design-related change orders, ensuring that design inputs, outputs, verification, validation, design reviews are appropriately defined, executed, and documented.
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.
Supports and participates in internal and external audits, including FDA and notified body inspections, with a focus on design controls, risk management, and product lifecycle compliance.
Ensures compliance with company policies, including Privacy/HIPAA, and all applicable regulatory, legal, and safety requirements.

Benefits

Tandem offers health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts.
You’ll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan.

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