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Senior Design Quality Engineer

Boston Scientific
Mar 05, 2025

Additional Location(s):US-MN-Plymouth; US-MN-Maple Grove

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:

Boston Scientific Peripheral Interventions has an opportunity for a Senior Design Quality Engineer to join our Vascular team to grow and develop our portfolio of products to treat carotid artery disease.

The Senior DQ Engineer will work cross-functionally to ensure safety, quality and compliance of the device while delivering the highest quality product to the customer. This role will serve as the Quality team lead on NPD, Sustaining, and/or Integration projects and will utilize quality engineering methodologies and practices which meet BSC, customer, and regulatory requirements.

This role offers a unique chance to gain end-to-end exposure to the full Product Life Cycle Process (PLCP) including design, development, integration, and sustaining of Medtech devices.

Your responsibilities will include:



  • Function as Quality Core Team member on project teams to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements
  • Gathers and uses clinical knowledge to influence how devices they are working on are evaluated and designed
  • Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects
  • Applies critical thinking and sound engineering analysis as part of systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Leads the implementation and development of product risk management tools (i.e., Hazard Analysis, Fault Tree, FMEAs)
  • Application of validation and statistical techniques to comply with associated regulatory requirements and internal standards and provide guidance to cross-functional team on the application of these techniques
  • Champions the culture of quality-centric patient care and customer satisfaction within the Peripheral Interventions team
  • Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines)
  • Advise management on potential improvements or enhancement to quality systems and processes in the company, and own actions to implement said improvements


Required qualifications:



  • BS in Mechanical / Biomedical Engineering or related discipline or equivalent combination of education and experience to perform at this level
  • 5+years' experience in design quality or related quality field; or equivalent combination of education and experience to perform at this level
  • 2+ years' experience with MedTech device design and development
  • Demonstrated use of Quality tools and methodologies with an emphasis on Design Controls and Risk Management
  • Experience leading Design Quality projects
  • Knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820 (US QS Regulation), ISO 13485 (Quality Management Systems), EU MDR, and IEC 62366-1 (Usability)
  • Ability to travel up to 10%


Preferred qualifications:



  • Demonstrated experience developing and launching catheter based medical devices
  • Strong technical knowledge, problem-solving capabilities, collaborative mindset, and effective communication skills
  • Comfortable working 'in the gray;' known for innovative, out of the box thinking to identify novel approaches to meeting requirements
  • Experience with devices used in the treatment of carotid artery disease
  • 1-2 years' supervisory experience of technical personnel
  • Working knowledge of human factors / usability engineering
  • Six Sigma Black Belt



#LI-Hybrid

Requisition ID:601907

Minimum Salary:$82600

Maximum Salary: $156900

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 identify, 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 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.


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