Sr Quality Engineer ; Hardware

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.

• 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, and 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, advanced statistical techniques (design margin, sensitivity analysis, process capability assessment), design of experiments, measurement system analysis, and reliability engineering.
• In partnership with the Risk Management team, uses 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.

This role will be a mix of in‑office work at our corporate headquarters in Del Mar, CA and remote work. The position is expected to be in office two days per week but may vary depending on business demands.

• Bachelor’s degree in a technical field, preferably Mechanical Engineering or equivalent education and applicable work experience.
• 5+ years’ experience working as a Quality Engineer in an FDA‑regulated hardware development environment, medical device development, or an FDA‑regulated industry.
• 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.
• Application of 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) and 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…