Principal Design Quality Engineer
Austin, TX, US, 73301
Additional Location(s): US-TX-Austin
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the role:
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.
Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Austin, TX office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities will include:
● 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.
Qualifications:
Required qualifications:
● 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%
Preferred qualifications:
● 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
Requisition ID: 621612
Minimum Salary: $ 97000
Maximum Salary: $ 184300
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
Nearest Major Market: Austin
Job Segment:
Six Sigma Black Belt, Biomedical Engineering, Six Sigma, Medical Device Engineer, Quality Engineer, Management, Engineering