Principal Design Quality Engineer
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Job Location:
Austin, TX - USA
Monthly Salary:
Not Disclosed
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
Additional Location(s):US-TX-Austin
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll 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:
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.
Required qualifications:
Bachelors 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 1020%
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 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) isnt just business its personal. And if youre 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 Companys policies or protocols change with regard to COVID-19 vaccination.
Among other requirements Boston Scientific maintains specificprohibited substancetest 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.
Required Experience:
Staff IC
About Company
Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.
