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Boston Scientific · 1 month ago

Senior Design Quality Assurance Engineer

Marlboro, MA

Full-time

Hybrid

Mid, Senior Level

$87K/yr - $164K/yr

5+ years exp

Boston Scientific is a leader in medical science committed to solving important health industry challenges. As a Senior Design Quality Assurance Engineer, you will ensure the safety, quality, and compliance of medical devices, supporting New Product Development and Quality Systems initiatives within a cross-functional team.

Health CareMedicalMedical Device

No H1B

Responsibilities

Serve as the primary quality representative within cross-functional product development teams, ensuring adherence to regulatory requirements and quality best practices

Lead quality deliverables such as Project Design & Development Plans, Field Assessment Plans, Design Changes, and Design & Usability Validation Plans. Ensure compliance with ISO 14971 and demonstrate a strong commitment to patient safety

Lead Risk Management activities and documentation throughout the design process

Function as a project leader or specialized technical team lead with cross-functional impact, including division-level representation on cross-divisional quality system initiatives

Apply systematic problem-solving tools such as 5 Whys, Is-Is Not, DMAIC, and Six Sigma to drive root cause identification and corrective actions

Mentor and coach engineers in quality engineering principles and problem-solving methodologies to promote a culture of learning and continuous improvement

Communicate quality priorities and recommendations to stakeholders across departments, using influence and negotiation to integrate quality into strategic decisions

Identify and implement improvements to quality systems and practices, championing best-in-class standards

Act as a subject matter expert during internal and external regulatory audits; support audit responses and submissions through high-quality technical writing

Qualification

Medical device engineeringRegulatory complianceRisk managementQuality engineeringSix Sigma certificationStatistical analysis softwareLeadership skillsCommunication skillsInterpersonal skillsProblem-solving skills