Sr Quality Engineer I - HardwareTandem Diabetes Care Inc. • Irvine, California, United States
Sr Quality Engineer I - Hardware
Tandem Diabetes Care Inc.
- Irvine, California, United States
- Irvine, California, United States
Über
A Senior Design Quality Engineer plays a critical role in ensuring the design, development, commercialization, and life‑cycle management of regulated medical devices meet the highest standards of regulatory compliance, design quality, reliability, and patient safety. The role provides quality leadership across the full product lifecycle, partnering with R&D, Regulatory Affairs, Clinical, Manufacturing, and Supplier Quality teams. Responsibilities
Serves as the Design Quality representative on new product development and sustaining engineering projects, providing quality leadership throughout the development lifecycle. Provides 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 execution of Design Controls in compliance with 21CFR820.30, ISO13485, and applicable global regulations, including planning, documentation, and maintenance of the Design History File. Ensures traceability between user needs, design inputs, design outputs, risks, verification, and validation activities, confirming residual risks are acceptable and documented. Drives and supports risk management activities in accordance with ISO14971, including hazard analysis, FMEA, implementation of risk controls, and maintenance of risk management files across the product life cycle. Independently applies and executes modern design quality engineering tools and methodologies including risk‑based analysis, advanced statistical techniques, design of experiments, measurement system analysis, and reliability engineering. Uses 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. Qualifications
Bachelor’s degree in a technical field, preferably Mechanical or Biomedical Engineering or equivalent education. 5+ years of experience as a Quality Engineer in an FDA‑regulated industry within design and development. Advanced understanding of Risk Management per ISO14971, hazard analysis, FMEA, risk control implementation, residual risk evaluation, and lifecycle maintenance of risk files. Proficient with statistical and analytical techniques (sampling theory, probability, capability analysis, test method validation, 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 (21CFRPart820) with demonstrated application of Design Controls (820.30) for regulated medical devices. Familiarity with design transfer requirements, manufacturability, testability, and contract manufacturing. Working knowledge of terminal sterilization modalities and sterile packaging systems (gamma radiation, e‑beam, ethylene oxide) and ability to assess design‑related risks. Understanding of electro‑mechanical and software systems, consumables, and packaging in 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 (molding, electronic assembly, surface‑mount technology, bonding methods, forming, machining). Hands‑on manufacturing expertise is not required but is considered desirable. WHEN & WHERE YOU’LL WORK
Hybrid: This role will be a mix of in‑office work at our Irvine Office and remote work. The position is expected to be in office 2–3 days per week but may vary depending on business demands. COMPENSATION & BENEFITS
The starting base pay range is $109,000 – $125,000 annually. Base pay will vary based on job‑related knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market. In addition to base pay, the package includes a competitive bonus structure and a robust benefits program: health, dental, vision available your first day; health savings accounts and flexible saving accounts; 11 paid holidays per year; a minimum of 20 days of paid time off (with accrual starting on day1); 401(k) plan with company match; and an Employee Stock Purchase plan. YOU SHOULD KNOW
Qualified applicants with arrest or conviction records will be considered in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer is contingent upon successful completion of a pre‑employment screening process comprising a drug test (excluding marijuana) and background check, which includes a review of criminal history information. This review is required to ensure individuals uphold high standards of trust and integrity for roles that may involve access to proprietary, sensitive, and/or confidential information, including customer protected health information. SPONSORSHIP
Applicants must be authorized to work for any employer in the U.S.; we are unable to sponsor employment visas at this time. Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization and welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone.
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Sprachkenntnisse
- English
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