Sr Design Quality Engineer I - Hardware

About the role

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.

Responsibilities

• Provides quality leadership across the full product lifecycle, from concept and product launch through sustaining engineering and post-market support.
• Serves as the Design Quality representative on new product development and sustaining engineering projects, providing quality leadership throughout the design and development lifecycle.
• Oversees and approves design verification and validation activities such as test strategies, protocols, reports, reliability testing, and compliance with the Quality Management System.
• Ledesigns 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.
• Partners with the Risk Management team to 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.

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).
• 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.

Qualifications

• Advanced degree in a technical field, preferably Mechanical or Biomedical Engineering.
• Experience in a regulated industry, particularly in design and development.
• Strong understanding of risk management and ISO 14971.
• Proficiency in statistical and analytical techniques relevant to medical device design.
• Knowledge of FDA Quality System Regulation (21 CFR Part 820) and Design Controls (820.30).
• Experience with terminal sterilization modalities and sterile packaging systems.
• Understanding of electro-mechanical and software systems, consumables, and packaging.
• Hands-on experience with common medical device manufacturing and assembly technologies.

Skills

• Statistical and analytical techniques
• Risk management and ISO 14971
• Design Controls and Quality Management System
• Medical device manufacturing and assembly technologies
• Electro-mechanical and software systems

Benefits

Tandem offers a competitive compensation package that includes a starting base pay range of $109,000 - $125,000 annually, health care benefits such as medical, dental, vision, and a 401k plan with company match, as well as an Employee Stock Purchase plan. Tandem is an equal opportunity employer and welcomes applications from a wide range of candidates.

Pay

$109,000 - $125,000 annually

Schedule

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 in Irvine but may vary depending on business demands and may require occasional trips to our San Diego Headquarters.