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. About the role: 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. Work mode: 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: Relocation assistance is available for this position at this time. Visa sponsorship: Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities include: 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 we’re looking for in you: Required Qualifications 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. Preferred Qualifications: 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. Requisition ID: 627583 Minimum Salary: $ 89200 Maximum Salary: $ 169500 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com— will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions : It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn . Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.