Design Assurance Engineer I

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:
The Design Assurance Engineer I 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.
 
Design assurance drives the ISO 14971 risk management process, Verification & Validation (V&V) process and supports software applications throughout the Software Development Lifecycle (SDLC) per IEC 62304 or equivalent standard. 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. Interfaces with all other quality and engineering components within the company and with customers and suppliers on quality related issues.
 
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 software 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.
Exercises understanding of software tools and technologies incorporated into design with thorough understanding of system and software design controls, participates in cross functional team meetings, software bug triage meetings to discuss, investigate and appropriately disposition software bugs and software related field issues. 
Follows software application development procedures and 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 principles 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, qualification, and on-going manufacturing of software and electronic products to meet or exceed internal and external standards or regulations.
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.
Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

What we’re looking for in you:
Required qualifications:

• Bachelor’s degree in computer science engineering, or related discipline
• Understanding of Software Development Lifecycle (SDLC)
• Understanding of software testing and issue investigation/ resolution
• Understanding of software configuration management (version control, Microsoft office tools)
• Knowledge of analytical techniques, problem solving and process improvement
• Strong written/verbal communication skills

Preferred qualifications:

• Previous Software Design Assurance or related 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 with Issue Tracking Tools (Jira) and Requirements/ Test Management Tools
• Knowledge of Cybersecurity and Cloud Computing concepts
• Knowledge of Artificial Intelligence/ Machine Learning concepts
   

Requisition ID: 593176

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

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!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.