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Über
Senior Design Quality Engineer plays a critical role in ensuring the design, development, commercialization, and lifecycle management of regulated medical devices meet regulatory compliance, design quality, reliability, and patient safety standards. Works with R&D, Regulatory Affairs, Clinical, Manufacturing, and Supplier Quality teams to provide quality leadership across the full product lifecycle from concept and product launch through sustaining engineering and post-market support. Lead and ensure 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). Ensure traceability between user needs, design inputs, design outputs, risks, verification, and validation activities, and confirm residual risks are acceptable and documented. Drive and support risk management activities per ISO 14971, including hazard analysis, FMEA, implementation of risk controls, and maintenance of risk management files across the product lifecycle. Review and approve new designs, design changes, design-related change orders, ensuring design inputs, outputs, verification, validation, and design reviews are defined, executed, and documented. Independently apply and execute modern design quality engineering tools and methodologies, including risk-based analysis (ISO 14971), advanced statistical techniques, design of experiments, measurement system analysis, and reliability engineering. Use postmarket data, complaint trends, and failure investigations to inform design improvements, risk reassessments, and verification strategy updates in partnership with the Risk Management team. Support and participate in internal and external audits, including FDA and Notified Body inspections, with a focus on design controls, risk management, and product lifecycle compliance. Ensure compliance with company policies, including Privacy/HIPAA, and all applicable regulatory, legal, and safety requirements. When & Where You’ll Work
This role will be a mix of in-office work at the corporate headquarters in Del Mar, CA and remote work. The position is expected to be in office 2 days per week but may vary depending on business demands. What You’ll Need
Bachelor's degree in a technical field, preferably Mechanical Engineering or equivalent education and experience. 5+ years' experience as a Quality Engineer in an FDA-regulated hardware development environment, medical device development, or related field. Experience in an ISO environment preferred. 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. Ability to apply statistical and analytical techniques to evaluate design margins, variability, tolerance decisions, and risk-based verification strategies. Strong knowledge of FDA Quality System Regulation (21 CFR Part 820) with demonstrated application of Design Controls (820.30) for regulated medical devices. Working knowledge of ISO 13485 and global design control expectations throughout the product lifecycle. Knowledge of design verification and validation principles, including risk-based test strategy development, reliability testing, and regulatory submission documentation. Familiarity with design transfer requirements, manufacturability, testability, and contract manufacturing considerations. Working knowledge of terminal sterilization modalities and sterile packaging systems, with ability to assess related design risks. Understanding of electromechanical and software systems, consumables, and packaging within a regulated design environment. Knowledge of postmarket quality systems, including complaint handling, failure investigation, CAPA, and feedback to design controls and risk management. Working knowledge of mechanical drawings and GD&T. Familiarity with common medical device manufacturing and assembly technologies and an understanding of how manufacturing capabilities influence design decisions and risk controls. General understanding of supplier quality within a design controls framework and collaboration with Supplier Quality teams. Understanding of regulatory inspection and technical review expectations for FDA audits and Notified Body assessments, particularly related to design documentation and risk management. Strong written and verbal communication skills to present technical quality information clearly to cross-functional teams, management, and external auditors. Compensation & Benefits
The starting base pay range for this position is $108,000 - $120,000 annually. Base pay varies based on job-related knowledge, skills, experience, location, and market conditions. Tandem offers a competitive compensation package that includes bonus and a robust benefits package, plus health care benefits available from day one, health savings accounts and flexible saving accounts, 11 paid holidays per year, a minimum of 20 days of paid time off (accrual starts on day 1), a 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 Fair Chance laws. A conditional offer is contingent upon successful completion of a pre-employment screening including drug test and background check. This role may involve access to proprietary and sensitive information, including customer protected health information, to ensure trust and integrity. Sponsorship
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. Why You’ll Love Working Here
At Tandem, we believe joy fuels excellence. We celebrate achievements and support well-being, while fostering growth and camaraderie. Learn more about Tandem’s benefits and culture on our careers page.
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Sprachkenntnisse
- English
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