Lead Design Quality Assurance Engineer

Boston Scientific; Marlborough (MA); Ibrido; USD 82.000 - 156.000; Tempo pieno

Descrizione del lavoro

Boston Scientific is seeking a Design Quality Assurance Engineer III in Marlborough, MA for a hybrid role. You will lead complex NCEP/CAPA activities across the product lifecycle, ensuring safety, quality and compliance while improving product value.

You will work with cross-functional teams to drive quality improvements and provide input on Design Controls. Responsibilities include guiding investigations, applying Six Sigma methodologies, and mentoring engineers to uphold best practices in

Competenze

• BS in Biomedical Engineering, Mechanical Engineering or related degree.
• Minimum of 3 years of medical device engineering experience.
• Detailed understanding of US and international medical device requirements including 21 CFR 820, MDD/EU MDR, EN ISO 13485 and EN ISO 14971.
• Proven experience leading and owning CAPAs within the design environment and proficiency in root cause analysis tools.
• Travel approximately 10-20%.

Mansioni

• Leads and provides quality oversight for complex design-related NCEP/CAPA activities, ensuring timely progression through all phases while maintaining regulatory and Quality System compliance.
• Applies systematic problem-solving methodologies (e.g., 5 Whys, Is-Is Not, DMAIC, Six Sigma) to diagnose root causes and optimize processes.
• Develops risk-appropriate corrective and preventive actions with cross-functional teams.
• Provides input on Design Controls (Design Change Analysis, Design Inputs/Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation, Labeling).
• Mentors engineers and promotes a culture of learning and technical excellence.
• Acts as primary voice for quality within cross-functional teams and ensures adherence to regulatory requirements and internal procedures.
• Identifies and implements best-in-class quality practices and supports regulatory audits.

Conoscenze

Medical device engineering

Regulatory knowledge

Root cause analysis

CAPA leadership

Travel readiness

Quality systems

Documentation & audits

Formazione

BS in Biomedical Engineering, Mechanical Engineering or related degree

Strumenti

Minitab

Statistical methods

Descrizione del lavoro

Boston Scientific is seeking a Design Quality Assurance Engineer III in Marlborough, MA for a hybrid role. You will lead complex NCEP/CAPA activities across the product lifecycle, ensuring safety, quality and compliance while improving product value.

You will work with cross-functional teams to drive quality improvements and provide input on Design Controls. Responsibilities include guiding investigations, applying Six Sigma methodologies, and mentoring engineers to uphold best practices in