Principal Design Quality Engineer

Boston Scientific•Austin, TX

23h•$97,000 - $184,300•Hybrid

About The Position

The Principal Design Quality Engineer is a seasoned professional responsible for championing quality excellence, regulatory compliance, and continuous improvement across the product development lifecycle. This role supports a design site within the Endoscopy Division, with focus areas including New Product Development (NPD), Sustaining and Life Cycle Management, and Quality Systems initiatives related to design and development. As a quality leader within cross-functional teams, this role plays a critical part in shaping the direction of product programs and influencing company-wide initiatives through technical depth, strategic insight, and collaborative leadership.

Requirements

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
Travel approximately 10–20%

Nice To Haves

10+ years' experience in medical device engineering
Expertise in Usability and Human Factors Engineering
Proficiency with Minitab or similar statistical analysis tools
Six Sigma Black Belt certification
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
Strategic mindset with the ability to execute hands-on and drive both short-term impact and long-term improvement

Responsibilities

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.