Additional Location(s): N/A
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. Examples of what this includes are:
- 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
What we're looking for in you:Required Qualifications
- 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
Preferred Qualifications:
- 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
Requisition ID: 634773Minimum Salary: $ 106800 Maximum Salary: $ 202900 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.Compensation for
non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for
exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
