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Engineer II, SW Design Assurance (Remote optional) Job

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Date: Sep 24, 2021

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific

Addtional locations: Remote optional


Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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.


Engineer II, Software Design Assurance


About the role:
The Design Assurance Engineer serves on a high-performing cross-functional R&D team to develop the next generation of world-class Cardiac Rhythm Management (CRM) systems.  The Design Assurance Engineer is an expert on the quality and safety of these complex and powerful systems, including the LATITUDE patient management system, digital health software, programmers, and active implantable medical devices (pacemakers, implantable defibrillators, and implantable cardiac monitors).  She or he owns the quality of the system from concept through commercialization, has a passion for the overall user experience, and sees the big picture as users interact with multiple tools, systems, and interfaces.  The initial focus of this position will be the LATITUDE Patient Management System and Digital Health Software.  This high visibility position provides the right candidate with excellent growth potential.


Your responsibilities include:

  • Understanding cardiac physiology and the therapies that treat cardiac arrhythmias;   
  • Applying sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
  • Analyzing post-market quality signals, voice of the customer (VOC) data, and human factors studies to inform plans, requirements, and designs for new products with world-class performance and safety;
  • Generating, reviewing, and approving quality records including project plans, market specifications, product specifications, design verification test protocols, design verification test reports, and requirements tracing reports;
  • Leading a cross-functional team to monitor, investigate, and resolve quality signals after product launch; 
  • Advocating for patients, physicians, economic users, and field personnel; actively promoting and participating in a cross-functional team environment;  
  • Learning, using, and teaching the most effective engineering tools to optimize software and systems designs – Human Factors Engineering, Benchmarking, Software Testing, and ad hoc Systems Testing.  This position is a technical, engineering job.


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

  • BS Degree in Electrical Engineering, Software Engineering, Biomedical Engineering, or a related discipline and 2 years of related work experience.  Alternatively, an MS Degree in Electrical Engineering, Software Engineering, Biomedical Engineering, or a related discipline with no other related work experience;
  • Self-motivated, result-oriented, critical thinker with a demonstrated bias for action;
  • Experienced problem solver, capable of facilitating a structured problem-solving process.
  • Strong communication skills (verbal & written) in office and remote settings;
  • Adaptable and effective engineer in a team environment or in self-directed work; 

Preferred qualifications:

  • Experience developing software code;
  • Hands on software and systems testing experience;
  • Experience in development of complex diagnostic or therapeutic medical systems;
  • Experience in pre-clinical studies, especially studies in cardiac rhythm management or electrophysiology.
  • Experience in the clinical setting, especially clinical trials or research studies in humans.
  • Experience in design assurance, post-market quality, or new product development;
  • Understanding of regulations applicable to medical device design controls and risk management, including FDA 21 CFR 820, ISO 13485, EN ISO 14971, MDD, AIMD, and, EU MDR.
  • Professional Certifications, including American Society for Quality Certified Quality Engineer


Requisition ID: 500759


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 is proud to be an equal opportunity and affirmative action employer.


Boston Scientific maintains a drug-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.


Nearest Major Market: Minneapolis

Job Segment: Medical, Physiology, Engineer, Electrical, Design Engineer, Healthcare, Engineering