Senior Design Assurance Engineer - Electrophysiology

Boston Scientific • Waltham, MA

6h • $89,200 - $169,500 • Hybrid

About The Position

We have a high-impact opportunity for a Senior Design Assurance Engineer to lead design assurance efforts for the Opal system, a critical medical device platform. This role requires a self-driven professional capable of independently managing complex quality and compliance activities across hardware and software domains. The Senior Engineer will drive quality initiatives, mentor junior engineers, and serve as a key resource in cross-functional teams to ensure product safety, regulatory compliance, and exceptional software quality.

Requirements

• Bachelor’s degree in Materials, Mechanical, Electrical, Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline.
• 6+ years of experience in Quality Assurance, Design Assurance, Software Quality, or related roles in the medical device industry.
• Demonstrated expertise in Design Controls, Risk Management (ISO 14971), Quality System Regulations (21 CFR 820), with deep knowledge of software quality standards (IEC 62304) and software validation principles.
• Proven ability to independently lead complex design assurance projects, including software quality assurance activities, from inception through completion.
• Experience developing and maintaining risk documentation such as FMEAs and Hazard Analyses with a software risk focus.
• Strong problem-solving skills with experience leading root cause analysis and CAPA investigations.
• Excellent communication skills, capable of influencing stakeholders at all levels and leading cross-functional initiatives.
• Ability to thrive in a fast-paced environment and navigate ambiguity with sound judgment.

Nice To Haves

• Experience mentoring or leading junior engineers in design assurance or software quality.
• Hands-on experience with software testing frameworks, static code analysis tools, or software risk analysis tools.
• Prior experience working on or supporting the Opal system or similar complex medical device platforms.
• Strong project management skills and familiarity with agile development methodologies.

Responsibilities

• Independently lead design control activities for the Opal system, including planning, execution, and documentation of risk management, design verification, and validation efforts, with a strong focus on software quality assurance.
• Collaborate closely with R&D, regulatory, manufacturing, and clinical teams to provide expert guidance on design assurance and compliance matters throughout the product lifecycle.
• Own and maintain comprehensive risk management files (Hazard Analysis, FMEAs), ensuring robust coverage of both hardware and software risks, applying advanced risk mitigation strategies.
• Lead root cause investigations and resolution of CAPAs, NCEPs, and complaints, driving corrective actions and preventive measures with minimal oversight.
• Champion software quality initiatives by enforcing compliance with IEC 62304, ISO 13485, and other relevant standards; lead software validation and verification activities including test planning, execution, and traceability.
• Provide mentorship and guidance to junior engineers on design assurance best practices, regulatory requirements, and software quality processes.
• Proactively identify gaps and opportunities for continuous improvement in design assurance processes, tools, and documentation.
• Act as a primary point of contact for design assurance during internal and external audits and regulatory inspections.
• Effectively manage multiple priorities and projects independently, demonstrating strong decision-making skills in ambiguous situations.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees