Senior Quality 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:

Boston Scientific ranked #2 among medical device companies on Forbes America's Best Places to Work for Engineers 2026. Whether your passion lies in systems, software, human factors, or beyond, this is a place where you can grow your career and be part of something bigger-advancing science for life.

We are seeking a quality-focused professional to drive key initiatives in sustaining product support, quality investigations, process improvements, and new product introductions. In this role, you will serve as a technical leader supporting manufacturing and engineering teams, ensuring compliance with rigorous industry standards while advancing patient safety and product quality.

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. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

* Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

* Collaborate with technicians and manufacturing engineers to identify manufacturing process defects, determine primary root causes, evaluate corrective and preventive actions, and disposition non-conforming material.

* May be responsible for defining product boundaries and establishing document release criteria.

* Use risk analysis tools-including but not limited to hazard analyses, DFMEA, and PFMEA-to evaluate and disposition product quality issues.

* Support process validation and verification activities, including test method validation, and generate/review related documentation.

* Identify potential sources of manufacturing defects and devise methods to reduce process variation and eliminate defects.

* Lead process improvement efforts by identifying methods to capture quality metric data and applying appropriate analysis techniques to enhance sustaining and new product development.

* Act as a team member in supporting quality disciplines, decisions, and practices.

* Participate in team decision making and demonstrate strong problem-solving and communication skills.

* Partner with Project Management and cross-functional teams to support new or updated products entering the manufacturing area.

* Provide process ownership and Material Review Board (MRB) support.

* Proactively investigate, identify, and implement best-in-class quality engineering practices.

* Mentor and support area Quality Technicians.

* Perform Device History Record (DHR) review and Final Product Release activities.

* Monitor and ensure compliance to internal quality systems and external industry regulations.

* Perform other duties as assigned.

Qualifications:

Required qualifications:
* Bachelor's degree in a scientific or engineering discipline, or equivalent combination of education and experience.

* Minimum of 2 years' experience (Quality Systems Engineer II) or minimum of 5 years' experience (Senior Quality Systems Engineer) in a pharmaceutical, medical device, or other highly regulated industry.

* Experience in capital equipment design and production or with similar medical devices while working within a Quality function.

* GMP experience within ISO 13485 and FDA 21 CFR Part 820 environments.

* Experience in risk analysis methodologies.

* Strong analytical, planning, and organizational skills.

* Strong interpersonal and communication skills (oral and written).

* Self-starter with ability to work independently under pressure and adapt to changing priorities.

* Proficient in MS Office (Word, Excel, PowerPoint, Project, Visio).

Preferred qualifications:
* Experience performing test method validation and Gage R&R studies.

* In-depth understanding of statistical techniques such as normality analysis and tolerance analysis, with demonstrated ability to analyze and interpret data confidently.

Requisition ID:621245

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 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.