Boston Scientific · 5 hours ago
Senior Design Quality Engineer
Marlborough, MA
Full-time
Hybrid
Mid, Senior Level
$89K/yr - $170K/yr
5+ years expBoston Scientific is a leader in medical science committed to advancing science for life. The Senior Design Quality Assurance Engineer will support medical device product development, ensuring safety, quality, and compliance while driving effective resolution of design-related issues.
Medical DeviceHealthcareHealth CareMedical
Responsibilities
Acts as the primary voice for quality within cross-functional teams, influencing project direction and ensuring adherence to regulatory requirements and best practices
Leads the end-to-end execution of the NCEP/CAPA process, ensuring timely investigation, root cause analysis, action implementation, and effectiveness verification in accordance with FDA, ISO 13485, and internal Quality System requirements
Oversees CAPA portfolio management, ensuring appropriate prioritization, resource allocation, and escalation to leadership for high-risk or system-level issues
May lead specialized technical project teams which have a broad impact on the company utilizing cross-functional resources. Acts as division representative on cross-divisional projects defining the quality system(s)
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
Guides and mentors engineers, 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. 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
Qualification
Required
Minimum of a Bachelors degree Biomedical Engineering, Mechanical Engineering or related degree
Minimum of 5 years of medical device engineering experience
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
Strong technical expertise in CAPA management, including root cause analysis, effectiveness verification, and implementation of sustainable corrective and preventive actions within a regulated medical device Quality System
Travel approximately 10-20%
Preferred
6+ 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
Benefits
Variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements)
Variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements)
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
H1B Sponsorship
Boston Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (114)
2024 (106)
2023 (93)
2022 (140)
2021 (111)
2020 (97)
Funding
Current Stage
Public CompanyTotal Funding
$10.01B2025-02-21Post Ipo Debt· $1.57B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
Medical Device Network
2026-02-10
2026-02-09
Company data provided by crunchbase