Engineer II, Quality

Additional Locations:  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:
The Design Assurance Engineer will interface with R&D and other supporting cross functional teams on development and maintenance of medical equipment with specific focus on software and cybersecurity elements.
 
The Design Assurance Engineer II will drive the ISO 14971 risk management process, Verification & Validation (V&V) process and support software applications throughout the Software Development Lifecycle (SDLC) per IEC 62304 or equivalent standard. He/she/they will manage the implementation of risk management as well as software design processes with compliance to company procedures including quality plans, risk management plans and reports, hazard analysis, product risk management workbook (design FMEA and software FMEA), statistical techniques, verification & validation protocols/testing/reports, software bug investigations and resolutions. He/she/they will interface with all other quality and engineering components within the company and with customers and suppliers on quality related issues.
 
The Design Assurance Engineer II will actively participate in all aspects of Design Control including systems and software. Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals, and priorities.

Your responsibilities include:

• Participates in the implementation of new product design (NPD) software and electronic design assurance: Risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design verification and validation, Design/Software Change Analysis Forms, Risk Change Analysis forms etc. Utilize statistical analysis techniques to determine product acceptance.
• Follows software application development procedures and provide support to demonstrate compliance through technical documentation generation.
• Thorough understanding of system and software design controls, participates in cross functional team meetings, software bug triage meetings to discuss, investigate and appropriately disposition internal software bugs and software field issues. 
• Participates in software and electronic design reviews, design transfers, and in all aspects of the Design Control process for the PCI Guidance products. Ensure customer requirements are met by incorporating engineering principals in robust design and in design for manufacturability. 
• Assists in design, develop, refine, and validation of device software test methods and inspection procedures. Guides/authors software design verification and design validation protocols and reports.
• Fully supports the Quality System by building quality into all aspects of the incumbent's work and to ensure compliance with corporate quality systems and software requirements, including non-functional requirements.
• Identifies and implements effective process control systems to support the software development, software tool validation, tool qualification, and on-going manufacturing of software and electronic products to meet or exceed internal and external standards or regulations.
• Facilitates Change Control Board (CCB) meetings to walk through software bugs occurred during design verification/ validation or field issues and assist in performing bug dispositions.
• Lead and participate in product failure investigations and root cause analysis.
• Participate in Cybersecurity related discussions and assist supporting activities driven by FDA Cybersecurity guidance.
• Directly interface with people performing internal and external audits.
• Provide technical guidance, training, and demo sessions to team members in various software features and functionalities, experimental design, data analysis, and product/process verification and validation.
• May develop technical solutions to complex problems and apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, which may include NCEP and CAPA ownership, core team member and coordination.
• Interface with agents of regulatory bodies as necessary to demonstrate quality system compliance. Support product submission and certification / recertification activities for US, European and other markets from software perspective.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Exercises understanding of software tools and technologies incorporated into design.
• All other duties as assigned.

Required Qualifications:

• Minimum of a Bachelor’s degree in Engineering, or related discipline
• Minimum of 2 years of Design Assurance or related experience
• Understanding of Software Development Lifecycle (SDLC)
• Experience with software testing and issue investigation/ resolution
• Demonstrated use of Quality tools/methodologies (Hazard Analysis, SW FMEA, Root Cause Analysis, Fault Tree, Fishbone etc.)

Preferred qualifications:

• Previous Software Design Assurance experience is a plus
• Medical device or other regulated industry experience
• Strong knowledge of Quality System Regulation (QSR), Risk Management standards (ISO 14971) and software standards (IEC 62304 or IEC 82304)
• Experience with Software code reviews
• Experience working in an Agile environment
• Experience with Issue Tracking Tools (Jira) and Requirements/ Test Management Tools
• Understanding of Quality Management System (QMS)
• Strong written/verbal communication skills

Requisition ID: 563553

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!