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:

Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

Apply your engineering expertise to ensure patient safety and product excellence by joining the Design Assurance team within our Structural Heart Valves division. As a Quality Design Assurance Engineer, you will support new product development and commercialized products that improve the delivery of care for patients around the world.

In this role, you will contribute to design strategy, risk management and lifecycle quality activities while partnering with cross-functional teams in R&D, manufacturing, regulatory and clinical. You will work in a collaborative, high-performance environment that values innovation, accountability and continuous improvement.

Work model, sponsorship, relocation:

This role is on-site in Carlsbad, California, to support hands-on collaboration and cross-functional partnership. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is available for qualified candidates.

Your responsibilities will include:

● Apply systematic problem-solving methodologies to support resolution of product and process quality issues across the product lifecycle

● Provide quality engineering support on cross-functional new product development teams, ensuring robust design inputs, verification and validation activities and regulatory compliance

● Support risk management activities, including hazard analysis and FMEAs, ensuring alignment with ISO 14971 and internal standards

● Develop, review and approve verification and validation protocols and reports, ensuring compliance with applicable regulatory requirements

● Establish, review and maintain Design History File documentation, including design requirements, specifications and design outputs

● Support design change control activities, assessing product and process impacts to ensure compliance and patient safety

● Monitor field performance of medical devices, analyze trends and support corrective and preventive actions as needed

● Contribute to continuous improvement initiatives that enhance product quality and team effectiveness

Qualifications:

Required qualifications:

● Bachelor of Science degree in Engineering or a related technical field

● Minimum of 3 years' experience in quality engineering or design assurance within the medical device industry

● Experience supporting risk management, design controls and product verification and validation

● Knowledge of global quality system regulations and standards, including ISO 13485 and ISO 14971

● Strong written and verbal communication skills

● Ability to manage multiple priorities in a fast-paced environment

Preferred qualifications:

● Degree in biomedical or mechanical engineering

● Experience supporting cardiovascular or implantable medical devices

● Certification in quality engineering (e.g., CQE) or related credential

● Experience applying quality tools and statistical methodologies

● Demonstrated commitment to continuous improvement and collaboration

Requisition ID: 625931 

Minimum Salary: $ 82100 

Maximum Salary: $ 156000 

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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

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.