Senior Design Quality Engineer

Boston Scientific • Georgetown, MA

5d

About The Position

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.

Requirements

• 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%.
• 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.

Nice To Haves

• 6+ years of medical device engineering experience.
• Proficiency in Minitab Statistical Analysis software or equivalent.
• Six Sigma Certification.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level