Principal Software Design Quality Assurance (DQA) Engineer - Urology

Boston Scientific•Marlborough, MA

5d•Hybrid

About The Position

Boston Scientific is a worldwide and diverse company that 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.

Requirements

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

Nice To Haves

10 years’ experience within Medical Device Software (Software in a medical device)
Master’s degree in Electrical Engineering, Computer Science, Software Engineering, or a related field.
Urology or equivalent experience
Experience with Software Development Lifecycle, Agile methodology, embedded software.
Proven ability to influence without authority

Responsibilities

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).
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.
Meet Boston Scientific and applicable Standards, based on risk controls identified
Review of requirements vs risks to define where the appropriate level of risk control lies
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 reports, etc. (required per IEC 62304) and Threat Modeling / Security Risk Analysis)
Represent Quality on change control boards (CCB) to inform quality based decisions and approvals.
Conduct safety reviews and determine applicability of NCEP/CAPA process on design changes.
Create and own design change assessment for software design changes for a given software release.
Support software design transfer to manufacturing and implementation and audit activities