Senior Design Assurance Engineer - Electrophysiology

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high‑performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

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.

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Waltham, MA and requires being on‑site at least three days per week.

Relocation assistance is available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• 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.

• 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.

• Experience mentoring or leading junior engineers in design assurance…