Senior Design Quality Engineer - Electrophysiology

Boston Scientific•Waltham, MA

12d•$89,200 - $169,500•Hybrid

About The Position

We have a high-impact opportunity for a Senior Design Quality Engineer to lead design assurance efforts for the Opal HDx Mapping System, a critical medical device platform in the Electrophysiology space. This role requires a self-driven professional capable of independently managing complex technical challenges and driving to solutions across hardware, software, and system domains. The Senior Engineer will influence strategic quality initiatives, mentor junior engineers, and serve as a key resource in cross-functional teams to ensure product safety, regulatory compliance, and design robustness.

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/system development principles.
Proven ability to independently lead complex product development projects, including software and system quality assurance activities, from inception through completion.
Experience developing and maintaining risk documentation such as FMEAs and Hazard Analyses with a software and system 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/systems engineering activities.
Hands-on experience with software testing frameworks, static code analysis tools, or software risk analysis tools.
Prior experience working on or supporting cardiac mapping systems or similar complex medical device platforms.
Strong project management skills and familiarity with agile development methodologies.

Responsibilities

Serve as the technical authority within Quality for system integration, design decisions, risk management, and software development & validation.
Independently lead design control activities for the Opal HDx Mapping System, including Design & Development planning, risk management, design verification, and validation efforts, with a strong focus on robustness of system design and documentation.
Collaborate closely with R&D, regulatory, manufacturing, and clinical teams to provide expert guidance on design and compliance matters throughout the product lifecycle.
Own and maintain comprehensive risk management files (Hazard Analysis, FMEAs), ensuring robust coverage of both hardware, software, and system risks, applying advanced risk mitigation strategies to influence robust design decisions
Lead root cause investigations and resolution of test failures, 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 product development 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, and ability to influence project team towards quality-centric decisions and behaviors