Principal DQA Engineer - Medical Device #2587

ECI

Brief Description

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About The Role

The Principal DQA Engineer will be responsible for championing quality excellence, regulatory compliance, and continuous improvement across the product development lifecycle. This role supports a design site with focus areas including New Product Development (NPD), Sustaining and Life Cycle Management, and Quality Systems initiatives related to design and development.

What You’ll Do

Act as the primary quality representative on cross-functional teams, influencing project direction and ensuring alignment with regulatory requirements and best practices.
Lead execution of quality deliverables such as Project Design & Development Plans, Field Assessment Plans, Design Changes, and Design & Usability Validation Plans.
Drive the creation and execution of Risk Management deliverables in compliance with ISO 14971, with a focus on patient safety.
Guide the successful completion of major programs and projects, functioning in a project leadership role when required.
Interface with senior management on strategic initiatives requiring coordination across organizational units.
Represent the division in cross-divisional projects and define quality system requirements.
Lead complex problem-solving activities using structured methodologies (e.g., 5 Whys, Is-Is Not, DMAIC, Six Sigma).
Provide technical leadership and mentorship to engineering teams, fostering a culture of learning and excellence.
Coach team members on quality engineering principles and structured problem-solving techniques.
Communicate quality priorities across departments, drive alignment on initiatives, and integrate quality into key business decisions.
Identify and implement best-in-class practices for quality engineering systems and proactively recommend improvements.
Serve as subject matter expert during internal and external audits; support regulatory submissions and technical writing as needed.

What We Look For

Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related technical field
Minimum of 7 years' experience in engineering within the medical device industry
In-depth knowledge of U.S. and international medical device regulations, including 21 CFR Part 820, MDD/EU MDR, ISO 13485, and ISO 14971
Strong technical expertise in quality engineering, design controls, and risk management
Experience leading structured problem-solving using tools such as DMAIC, 5 Whys, or Six Sigma
10+ years' experience in medical device engineering
Proficiency with Minitab or similar statistical analysis tools
Proven ability to mentor, influence, and guide engineering teams and cross-functional stakeholders
Excellent communication and presentation skills with the ability to collaborate across functions and levels

All candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.

ECI is an equal opportunity employer

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.