Principal Design Quality Assurance Engineer - Endoscopy

Boston Scientific; Marlborough (MA); Hybrid; USD 97,000 - 184,300; Full time

Job summary

Boston Scientific is seeking a Principal Design Quality Assurance Engineer for the Endoscopy Division in Marlborough, MA. This hybrid on-site role requires 3 days/week on-site, with relocation assistance possibly available.

You will drive quality deliverables, oversee regulatory compliance, and mentor teams to ensure patient safety and continuous improvement. The role covers design development, life cycle management, and quality systems initiatives, with travel 10–20% and a strong emphasis on

Qualifications

• BS in BiomedicalEngineering, MechanicalEngineering or related degree.
• 8+ years of medical device engineering experience.
• Knowledge of US and international medical device requirements including 21 CFR 820, MDD/MDR, EN ISO 13485 and EN ISO 14971.
• Travel approximately 10-20%.

Responsibilities

• Act as the primary voice for quality within cross-functional teams, influencing project direction and ensuring regulatory compliance.
• Lead the execution of Quality Deliverables (Design & Development Plan, Field Assessment Plan, Design Change, Usability Validation Plans) and Risk Management deliverables per ISO 14971.
• Interface with senior management on significant matters and coordinate activity across organizational units.
• Apply systematic problem-solving approaches (e.g., 5 Whys, DMAIC, Six Sigma) to diagnose root causes and optimize processes.
• Mentor engineers and foster a culture of learning and technical excellence.

Skills

Quality engineering

Regulatory requirements

Project leadership

Root cause analysis

Process improvement

Cross-functional collaboration

Mentoring

Quality systems

Education

Bachelor's degree in Biomedical Engineering or Mechanical Engineering

Tools

Minitab

Six Sigma Black Belt

Job description

Additional Location(s): US-MA-Marlborough; 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 this role:

The Principal DesignQuality AssuranceEngineer isa seasonedprofessional withexperiencein quality engineering and regulatory requirements for the medical device industry.This roleserves as a driving force in the quality department, championing excellence, compliance, and continuous improvement across projects and teams.Thepositionis part of the design site for the Endoscopy Division andsupportsactivities such as New Product Development, Sustaining and Life Cycle Management, and Quality Systems initiatives related to design and development.

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 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:

• Acts as the primary voice for quality within cross-functional teams, influencing projectdirection and ensuring adherence to regulatory requirements and best practices.
• Leadsthe execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, Design Change, and Design & Usability Validation Plans. Leadsthe execution of the Risk Management deliverables to ensure compliancetoISO 14971 anddemonstratesa primary commitment to patient safety.Guides the successful completion of major programs and may function in a project leadership role.
• Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized technical project teams which have a broad impact on the companyutilizingcross-functional resources.Actsas division representative on cross-divisional projects defining the quality system(s).
• Leverages deep technical knowledge to lead teams through complex problem-solving initiatives. Appliessystematic approaches (e.g.5 Whys, Is-Is Not, DMAICand Six Sigmaproblem solving methodologies)todiagnose root causes,optimizeprocesses, and ensure sustained corrective actions.
• Guides andmentorsengineers, fostering a culture of learning, collaboration, and technical excellence. Provides coaching on quality engineering methodologies and problem-solving techniques.
• Establishes strong relationships across departments, effectively communicating quality priorities, presenting findings, and driving consensus among stakeholders.Usesinfluence and negotiation skills to integrate quality perspectives into business decisions.
• Identifiesand implements best-in-class practices forthe department. Proactively assesses opportunities forimprovements or enhancement to quality systems and processes in the company.
• Supportsinternal and external regulatory audits asauditfacing subject matterexpertasrequired.Supports regulatory responses through technical writing and submission consultation asrequired.

What we're looking for in you:

RequiredQualifications

• BS inBiomedicalEngineering,MechanicalEngineeringor related degree.
• 8+ yearsofmedical deviceengineering experience.
• In-depth knowledge of US and Internationalmedical devicerequirementsincluding 21 CFR part 820, Medical Device Directive(MDD)/ Medical Device Regulation(EU MDR), EN ISO 13485 and EN ISO 14971.
• Travelapproximately10-20%.

Preferred Qualifications

• 10+ years of medical device engineeringexperience.
• Sustaining Experience
• NPDExperience
• ExpertiseinUsabilityandHuman Factors engineering.
• ProficiencyinMinitab Statistical Analysis software or equivalent.
• Six SigmaBlack BeltCertification.

Requisition ID:631837

Minimum Salary:$97000

Maximum Salary: $184300

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 byprovidinga 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,neurologicaland 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 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.