Senior Medical Device Software DQA Engineer (Hybrid)

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

Benefits offered by this job

Relocation assistance

Job summary

Boston Scientific is seeking a Software DQA Engineer in the Urology division to develop and maintain MES software within regulatory guidelines.

You will lead project teams, ensure compliance with EN 62304, FDA guidance, and ISO 13485, and collaborate with R&D to deliver safe, high-quality medical device software. This hybrid role requires on-site presence in Marlborough, MA or Maple Grove, MN.

Qualifications

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

Responsibilities

• Lead DQA project teams with Product Development Engineers to create/update hardware/software documentation per EN 62304, FDA guidance, and internal procedures.
• Identify potential failure modes and risk controls for complex medical device systems including cybersecurity.
• Own risk-based requirements definition within the Quality System (21 CFR 820/ISO 13485) for medical device software (IEC 62304).
• Create and maintain risk management and usability documentation.
• Participate in usability/design validation activities.
• Prepare and review Software documentation (development plans, design reports, DV plans, protocols) per IEC 62304.
• Represent Quality on change control boards (CCB) and assess safety and CAPA processes.
• Create and own design change assessments for software releases.
• Support software design transfer to manufacturing and audits.

Skills

Microsoft Office

Jira

Python

Linux

Requirements management

Communication

Presentation

Travel readiness

Education

Bachelor's degree in Electrical Engineering, Computer Science, Software Engineering, or a related field

Tools

Jira

Python

Linux

Requirements management system

Job description

Boston Scientific is seeking a Software DQA Engineer in the Urology division to develop and maintain MES software within regulatory guidelines.

You will lead project teams, ensure compliance with EN 62304, FDA guidance, and ISO 13485, and collaborate with R&D to deliver safe, high-quality medical device software. This hybrid role requires on-site presence in Marlborough, MA or Maple Grove, MN.