Principal Design Quality Engineer - Remote

Overview

The Principal Design Quality Engineer will lead the process to ensure the design, development, and lifecycle management of Sequel’s software products meet regulatory and quality requirements.

In Short

• Lead design quality activities throughout the product development lifecycle.
• Ensure compliance with FDA, ISO 13485, ISO 14971, IEC 62304.
• Collaborate with cross-functional teams to establish robust design control processes.
• Support software development teams in implementing software quality assurance best practices.
• Participate in internal and external audits for compliance.
• Act as a quality engineering leader within cross-functional teams.
• Provide mentorship and guidance to junior engineers.
• Communicate quality and regulatory risks effectively to stakeholders.
• Drive continuous improvement initiatives in design quality processes.
• Support regulatory submissions and external audits.

Requirements

• Bachelor's degree in Engineering or related field (Master's preferred).
• 5+ years of experience in design quality engineering within the medical device industry.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304.
• Experience in design verification & validation, risk management, and cybersecurity compliance.
• Excellent communication and collaboration skills.
• Experience with insulin pumps or related diabetes care technologies preferred.
• Familiarity with Agile software development methodologies preferred.
• Six Sigma or ASQ certification is a plus.

Benefits

• 401k plan with a 6% company match and 100% immediate vesting.
• Multiple medical plans with capped out-of-pocket insulin costs.
• Vision and dental plans, employer-paid short-term disability.
• Flexible PTO and generous paid holidays.
• Supportive work culture that values hard work and fun.