Principal Design Quality Engineer

About Sequel
Sequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.
Job 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. This role will serve as a key quality representative within cross-functional teams, providing leadership in design controls, risk management, software quality, and product verification/validation. The ideal candidate will have extensive experience in design quality engineering for software as a medical device (SaMD) or software integrated within a medical device, preferably within an agile and/or startup development environment. He / she will as well have solid experience into designing and coordinating risk management activities for software.
Job Responsibilities and Essential Duties
Design Quality & Risk Management

• Own the design history file for software product(s) including the design and development plan, software requirements specification, software architecture and
• In partnership with the product management and product design leaders, lead design quality activities throughout the product development lifecycle, ensuring compliance with FDA, ISO 13485, ISO 14971, IEC 62304, and other applicable standards.
• Collaborate with Software Engineering, Medical Affairs, and Regulatory teams to establish robust design control processes, SW lifecycle processes and risk management strategies. Develop and maintain required risk management documentation, including hazard analyses, DFMEAs, and risk control measures.
• Ensure design verification and validation activities meet regulatory expectations, including software validation per IEC 62304.

Software & Systems Quality

• Support software development teams in implementing software quality assurance (SQA) best practices for embedded and standalone software within medical devices.
• Ensure traceability between software requirements, design outputs, verification testing, and risk assessments.
• Partner with cybersecurity and regulatory teams to ensure compliance with cybersecurity regulations and standards.

Regulatory Compliance & Audits

• Support regulatory assessments by providing design quality documentation and responses to regulatory inquiries.
• Participate in internal and external audits, ensuring compliance with FDA QSR, ISO 13485, and other global regulatory requirements.
• Lead or contribute to continuous improvement initiatives in design quality processes, driving efficiency and effectiveness in product development.

Collaboration & Leadership

• Act as a quality engineering leader within cross-functional teams, ensuring quality is integrated throughout the product lifecycle.
• Provide mentorship and guidance to junior engineers and quality team members.
• Communicate quality and regulatory risks effectively to stakeholders, enabling data-driven decision-making.

Minimum Requirements

• Bachelor’s degree in Engineering, Biomedical Engineering, or a related technical field (Master’s preferred).
• Minimum 5+ years of experience in design quality engineering within the medical device industry, preferably in diabetes technology, insulin delivery systems, or wearable medical devices.

Required Knowledge, Skills and Abilities

• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, and related medical device standards.
• Experience supporting software development lifecycles and software validation in a regulated environment.
• Demonstrated expertise in design verification & validation (V&V), risk management, human factors engineering, and cybersecurity compliance.
• Experience supporting regulatory submissions (e.g., 510(k), PMA, CE Mark) and external audits.
• Strong problem-solving, root cause analysis, and CAPA management skills.
• Excellent communication and collaboration skills, with the ability to influence cross-functional teams.
• Experience with insulin pumps, continuous glucose monitors (CGMs), or related diabetes care technologies preferred.
• Familiarity with Agile software development methodologies in a regulated environment preferred.
• Familiarity with agile regulatory pathways (Predetermined Change Control Plans, etc.) preferred.
• Knowledge of AI/ML-based software applications in medical devices preferred
• Six Sigma or ASQ certification (CQE, CSQE) is a plus.

Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
At Sequel, we believe that when you thrive, we thrive. That’s why we’ve designed a benefits package that’s as thoughtful as it is generous. From day one, you’re automatically enrolled in our 401k plan—no waiting, no worries—with a 6% company match and 100% immediate vesting. We prioritize your well-being, especially for our employees and their families living with diabetes, with capped out-of-pocket insulin costs and GLP-1 coverage across all plans. With multiple medical plans through Aetna, including a 100% company-paid high deductible plan paired with employer HSA contributions, you can select what suits your needs. Additional benefits include vision and dental plans, employer-paid short-term disability, and voluntary options like accident and pet insurance.
Need time to relax and recharge? You’ll enjoy flexible PTO and generous paid holidays, all while being part of a culture that values hard work, fun, and support. We don’t just offer jobs—we offer careers that build futures. Join us, and let’s grow together!
Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
• May work extended hours during peak business cycles
• Physical requirements such as lifting specific weights
• Some travelling is expected