Senior Design Quality Engineer - Endoscopy

Boston Scientific; Marlborough (CT); Hybrid; USD 89,000 - 170,000; Full time

Job summary

Boston Scientific is seeking a Senior Design Quality Assurance Engineer to support the Endoscopy portfolio. The role focuses on transforming technical insights into product improvements and portfolio value creation.

The position requires on-site presence in Marlborough, MA at least three days per week and offers relocation assistance. The candidate will work with cross-functional teams to ensure design controls and risk management meet regulatory standards.

Qualifications

• BS in Biomedical Engineering or related field.
• 5+ years of medical device engineering experience.
• Firm understanding of DMAIC and proven problem solving history.
• Knowledge of US and international medical device requirements including 21 CFR 820, EU MDR, EN ISO 13485 and EN ISO 14971.
• Travel approximately 10-20%.

Responsibilities

• Lead teams through complex problem-solving initiatives using structured methods (5 Whys, Is-Is Not, DMAIC, Six Sigma).
• Create and interpret data to support data-driven decisions.
• Act as the primary voice for quality within cross-functional teams and ensure regulatory compliance.
• Lead execution of Design & Development Plans, Field Assessment Plans, and Design Change Analyses.
• Lead Risk Management deliverables to ensure ISO 14971 compliance and patient safety.
• Communicate quality priorities across departments and drive consensus with stakeholders.
• Identify and implement best-in-class quality system improvements.

Skills

Medical device engineering

DMAIC problem solving

Root cause analysis

Quality mindset

Education

BS in Biomedical Engineering

Mechanical Engineering

Tools

Minitab

Six Sigma

Job description

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 this role:

The Senior Design Quality Assurance Engineer will provide direct DQA support to a team focused on solving complex technical challenges across the Endoscopy portfolio and transforming technical insights into meaningful product improvements, design enhancements, and portfolio value creation.

The position is part team that will engage in the most critical and complex issues impacting performance across the portfolio. Through that work, they will enable the longer-term objective of building a robust pipeline of iterative innovations, design improvements, and market-facing product enhancements.

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:

• Leverages deep technical knowledge to lead teams through complex problem-solving initiatives. Applies systematic approaches (e.g. 5 Whys, Is-Is Not, DMAIC and Six Sigma problem solving methodologies) to diagnose root causes, optimize processes, and ensure sustained corrective actions.
• Create and interpret data needed to make the best data driven decisions possible.
• Acts as the primary voice for quality within cross-functional teams, influencing project direction and ensuring adherence to regulatory requirements and best practices.
• Lead the execution of Quality Deliverables such as Project Design & Development Plan, Field Assessment Plan, Design Change Analysis, and Design & Usability Validation Plans.
• Leads the execution of the Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety.
• Establishes strong relationships across departments, effectively communicating quality priorities, presenting findings, and driving consensus among stakeholders. Uses influence and negotiation skills to integrate quality perspectives into business decisions.
• Identifies and implements best-in-class practices for the department. Proactively assesses opportunities for improvements or enhancement to quality systems and processes in the company.

What we’re looking for in you:

Required Qualifications

• BS in Biomedical Engineering, Mechanical Engineering or related degree.
• 5+ years of medical device engineering experience.
• Firm understanding of DMAIC system and proven history of problem solving
• Detailed understanding and working knowledge of US and International medical device requirements including 21 CFR part 820, Medical Device Directive (MDD) / Medical Device Regulation (EU MDR), EN ISO 13485 and EN ISO 14971.
• Travel approximately 10-20%.

Preferred Qualifications

• 8+ years of medical device engineering experience.
• Proficiency in Minitab Statistical Analysis software or equivalent.
• Six Sigma Certification.
• Strong technical expertise in quality engineering principles, design controls, risk management, and problem-solving methodologies.
• Excellent communication, presentation, and interpersonal skills, with the ability to influence teams and leadership.
• Proven ability to lead and coach others, driving a high-performance quality culture.
• Strategic mindset with hands‑on execution, balancing long‑term objectives with immediate project needs.

Requisition ID: 634795

Minimum Salary: $ 89200

Maximum Salary: $ 169500

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 atwww.bostonscientific.comand follow us onLinkedIn.

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.