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:
The Design Quality Assurance Engineer III provides quality engineering support and expertise across the product lifecycle, including new product development, design transfer, product changes, sustaining engineering, material continuity, regulatory compliance, corrective and preventive actions, and post-market support activities. Working in a fast-paced cross-functional environment, this role partners with Research & Development, Operations, Supplier Quality, Manufacturing, Regulatory Affairs, Clinical, and Marketing teams to ensure products are safe, effective, compliant, and meet customer and business needs. The engineer serves as a quality representative, championing patient safety, product quality, risk-based decision making, and continuous improvement.
Work mode:
At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Marlborough, MA and requires being on-site at least three (3) days per week.
Relocation assistance:
Relocation assistance may be available for this position at this time.
Visa sponsorship:
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time
Your Responsibilities Include:
Provide quality engineering support for new product development, product enhancements, design transfers, design changes, and sustaining engineering projects.
Partner with cross-functional teams to ensure compliance with Product Development Process, Design Controls, Risk Management, and applicable Quality System requirements.
Lead or support design change projects including project scoping, impact assessment, implementation, and effectiveness verification.
Develop, review, update, and maintain Design History File documentation and design input/output records.
Lead or support risk management activities including Hazard Analyses, Use-Related Risk Analyses, Task Analyses, Design FMEAs, and benefit-risk assessments.
Develop and execute Design Verification, Design Validation, Usability, and other qualification protocols and reports.
Serve as a quality representative on project teams, providing guidance on quality system requirements, design controls, standards compliance, and regulatory expectations.
Support investigations and resolution of complaints, nonconformances, CAPAs, product investigation reports, audit observations, field actions, and supplier quality issues.
Apply structured problem-solving methodologies to identify root causes, assess risk, and implement effective corrective actions.
Monitor post-market data, complaint trends, and product performance signals to assess risk and drive quality improvements.
Support supplier qualification, audits, co-development activities, and ongoing supplier performance monitoring.
Participate in internal, external, customer, and regulatory audits and inspection readiness activities.
Drive continuous improvement initiatives focused on product quality, manufacturability, reliability, compliance, and cost effectiveness.
Required Qualifications
Bachelor's degree in Engineering or related technical discipline.
Minimum 4 years of experience in Design Assurance, Quality Engineering, Product Development, or a related role within a regulated industry.
Knowledge of Design Controls, Risk Management, Quality Systems, and Good Documentation Practices.
Strong analytical, technical writing, communication, and problem-solving skills.
Experience working effectively within cross-functional teams.
Preferred Qualifications
Bachelor's degree in Mechanical, Electrical, Biomedical, or related Engineering discipline.
Medical device industry experience.
Experience with Design Controls, Risk Management, CAPA, and medical device standards compliance.
Knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, IEC 62366, and/or IEC 62304.
ASQ Certified Quality Engineer (CQE) and/or Six Sigma Green Belt or Black Belt certification.
Requisition ID: 635489
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.
Boston Scientific Quincy, Massachusetts, USA Office
500 Commander Shea Boulevard , Quincy, United States
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