Principal Software Design Quality Assurance (DQA) Engineer - Urology

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: 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 electrial 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. Work mode: This hybrid role is based in Marlborough, MA or Maple Grove, MN and requires being on-site at least three (3) days per week. Relocation assistance: Relocation assistance may be 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: Lead DQA project teams by working with Product Development Engineers (embedded within R&D) to create / review Hardware/Software systems including Cybersecurity to create or update project documentation to meet the requirements of EN 62304, FDA guidance documents and internal procedures. Identify possible failure modes/risk control opportunities for these complex systems (FDA/EUMDR-Regulated Class II Medical Device environments (including interconnected and cloud-based software systems). Examples of what this includes are:’ Review of SW/HW sub-systems (PCBA’s, FPGAs, with and without Firmware, etc.) and identify 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.…