Principal Software Design Quality Assurance (DQA) Engineer - Urology

About the Role

Boston Scientific is a world wide and diverse company who puts patients first. Through this position, the ideal candidate would use their software experience to support, develop, establish and maintain hardware/software within medical electrical systems (MES) for both Sustaining and New Product Development (NPD) within the Urology Division of Boston Scientific (BSC). Our team is all about building the future of the operating room for Urologists. As the industry leader in surgical kidney stone treatment, we are on a mission to empower physicians to treat more cases, more efficiently, with better outcomes; to help patients in need get back to their daily lives. As a Software DQA Engineer, you’ll be at the heart of that mission to develop best‑in‑class products to bring advanced, safe innovations to the clinic. You will also be supporting the effort to establish and maintain medical electrical systems (MES) products in partnership with the greatest minds in the entire medical device industry. Your contributions will directly impact patient care at a company widely regarded as being a quality leader in the medical device industry.

Responsibilities

• Lead DQA project teams by working with Product Development Engineers (embedded within R&D) to create/review hardware/software systems including cybersecurity, and to create or update project documentation to meet the requirements of EN 62304, FDA guidance documents, and internal procedures.
• Identify possible failure modes and risk control opportunities for these complex systems (FDA/EUMDR‑regulated Class II medical device environments, including interconnected and cloud‑based software systems). Examples include reviewing SW/HW sub‑systems (PCBAs, FPGAs, with and without firmware, etc.) and identifying risk control measures.
• Partner with R&D team members and own the identification of risk‑based requirements definition within the Boston Scientific Quality System (21 CFR 820/ISO 13485) for the medical device software process, IEC 62304. This includes meeting Boston Scientific and applicable standards based on identified risk controls, and reviewing requirements versus risks to define the appropriate level of risk control.
• Own the creation and maintenance of risk management and usability documentation; participate in conducting usability and design validation activities.
• Participate in the creation and/or review of software documentation (Software Development Plan, Detailed Design, software safety class, software DV test plans, protocols and