Software Design Quality Engineer II

Boston Scientific

  • Maple Grove, MN
  • $69,500 per year
  • Permanent
  • Full-time
  • 20 days ago
Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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:We have an exciting opportunity for a software-focused Design Quality (or Design Assurance) Engineer II supporting a cross-functional team on development and maintenance of capital equipment firmware and software within the Interventional Cardiology (IC) division. This position will support a significant product development project with high visibility which will provide the right candidate with excellent growth potential and product development experience. This role will apply the directives of design controls supporting the software development lifecycle (SDLC), software verification and validation (V&V), risk management, product development, and regulatory and standards compliance. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.This role 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.At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Maple Grove office at least three days per week.Relocation assistance is available for this position.Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.Your responsibilities include:
  • Participates in the implementation of new product software, including risk management (per ISO 14971), hazard analysis, software FMEAs, security risk analysis, software design V&V
  • Applies software application development procedures and provides support to demonstrate compliance through technical documentation generation.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. software bugs).
  • Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
  • Update and maintain software risk management tools (i.e. Hazard Analysis, FMEAs).
  • Participate in Cybersecurity related discussions and assist supporting activities
  • Assist in the design and development of software test methods and inspection procedures.
  • Support regulatory submissions to notified bodies.
  • 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:Required qualifications:
  • Bachelor’s degree in computer science, computer engineering, or related discipline
  • Minimum of 3 years of experience in design assurance, quality, new product development, or related medical device/regulated industry
  • 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:
  • Prior 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 (i.e. JIRA) and Requirements/ Test Management Tools
  • Knowledge of Cybersecurity and Cloud Computing concepts
  • Knowledge of Artificial Intelligence/ Machine Learning concepts
Requisition ID: 611805Minimum Salary: $ 69500Maximum Salary: $ 132000The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see --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.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 status, age, mental or physical disability, genetic information or any other protected class.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.Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Boston Scientific