Senior Medical Device Software Quality Engineer

Boston Scientific; Marlboro (MA); Hybrid; USD 107,000 - 203,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Boston Scientific is seeking an experienced engineer to support, develop, establish, and maintain hardware/software within medical electrical systems (MES) for the Urology division. The role focuses on regulatory compliance, risk management, and documentation across software and hardware components in a hybrid environment.

You will collaborate with Product Development Engineers, drive risk-based requirements, and ensure alignment with EN 62304, FDA guidance, and ISO 13485 standards while working

Qualifications

• Bachelor’s degree in Electrical Engineering, Computer Science, Software Engineering, or a related field.
• 8 years of experience in a regulated industry.
• Proficient with Microsoft Office Suite, a requirements management system, Jira, Python, Linux.
• Travel approximately 10–15% of the time as required.
• Strong communication and presentation skills.

Responsibilities

• Lead DQA project teams with R&D to create and review hardware/software systems and documentation per EN 62304 and FDA guidance.
• Identify potential failure modes and risk control opportunities for complex FDA/EU MDR environments.
• Review SW/HW subsystems and define risk controls within the Quality System per 21 CFR 820 / ISO 13485.
• Partner with R&D to define risk-based requirements and ensure compliance to IEC 62304.
• Create and maintain risk management and usability documentation; conduct usability/design validation activities.
• Represent Quality on change control boards and oversee software change assessments for releases.

Skills

Microsoft Office

Requirements management

Communication

Presentation

Education

Bachelor’s degree in Electrical Engineering, Computer Science, or Software Engineering

Master’s degree (preferred) in Electrical Engineering, Computer Science, or Software Engineering

Tools

Jira

Python

Linux

Job description

Boston Scientific is seeking an experienced engineer to support, develop, establish, and maintain hardware/software within medical electrical systems (MES) for the Urology division. The role focuses on regulatory compliance, risk management, and documentation across software and hardware components in a hybrid environment.

You will collaborate with Product Development Engineers, drive risk-based requirements, and ensure alignment with EN 62304, FDA guidance, and ISO 13485 standards while working