Senior Design Quality Assurance Engineer

Additional Location(s):  N/A

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:

As a Senior Design Quality Assurance Engineer at Boston Scientific, you will be instrumental in ensuring the safety, quality, and compliance of our medical devices from concept through commercialization. You will be embedded in a high-performing cross-functional team within the Endoscopy Division, supporting New Product Development, Sustaining Engineering, Life Cycle Management, and Quality Systems initiatives. This role offers the opportunity to influence product direction while enhancing commercial value through technical expertise and quality leadership.

This is a hybrid position based out of Marlborough, MA.

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 local 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:

● Serve as the primary quality representative within cross-functional product development teams, ensuring adherence to regulatory requirements and quality best practices.

● Lead quality deliverables such as Project Design & Development Plans, Field Assessment Plans, Design Changes, and Design & Usability Validation Plans. Ensure compliance with ISO 14971 and demonstrate a strong commitment to patient safety.

● Lead Risk Management activities and documentation throughout the design process.

● Function as a project leader or specialized technical team lead with cross-functional impact, including division-level representation on cross-divisional quality system initiatives.

● Apply systematic problem-solving tools such as 5 Whys, Is-Is Not, DMAIC, and Six Sigma to drive root cause identification and corrective actions.

● Mentor and coach engineers in quality engineering principles and problem-solving methodologies to promote a culture of learning and continuous improvement.

● Communicate quality priorities and recommendations to stakeholders across departments, using influence and negotiation to integrate quality into strategic decisions.

● Identify and implement improvements to quality systems and practices, championing best-in-class standards.

● Act as a subject matter expert during internal and external regulatory audits; support audit responses and submissions through high-quality technical writing.

Qualifications:

Required qualifications:

● Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.

● Minimum of 5 years' experience in medical device engineering.

● Detailed understanding of U.S. and international regulatory requirements including 21 CFR Part 820, MDD/EU MDR, ISO 13485, and ISO 14971.

● Ability to travel approximately 10–20%.

Preferred qualifications:

● Minimum of 6 years' experience in medical device engineering.

● Proficiency with Minitab or equivalent statistical analysis software.

● Six Sigma certification.

● Strong expertise in design controls, quality engineering, risk management, and technical problem-solving.

● Excellent communication and interpersonal skills with proven ability to influence teams and leadership.

● Demonstrated leadership and mentoring capabilities in a quality-driven environment.

● Strategic mindset with the ability to manage hands-on project needs and long-term initiatives.

#LI-Hybrid

Requisition ID: 617814 

Minimum Salary: $ 86600 

Maximum Salary: $ 164500 

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.