Boston Scientific Senior Design Assurance Engineer 

United States, Massachusetts, Waltham 

330833225

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.

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.