Senior Quality Systems Engineer- Medical Electrical Equipment

Boston Scientific

  • Arden Hills, MN
  • $82,600 per year
  • Permanent
  • Full-time
  • 2 months 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 Senior Design Quality Engineer supporting Medical Electrical Equipment within Boston Scientific’s Electrophysiology Division. In a hybrid or on-site work mode, the Senior Design Quality Engineer will work cross-functionally to ensure safety, quality, and compliance of Legacy Medical Electrical Equipment. This role will serve as quality lead in maintaining the design, development, verification, validation, and maintenance throughout the Product Life Cycle Process.At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be in our local office five days per week.Relocation assistance is not available for this position at this time.Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.Your responsibilities will include:
  • Maintain legacy fielded product on the market in an efficient and strategic manner
  • Support Post Market reports to include PMVP, PMVR, PMSR, as well as other reports.
  • Develop/document Quality Project Tracking Plans as well as Quality System Process Deviations
  • Support internal and external audits and audit responses to existing products.
  • Monitors compliance with company policies and procedures
  • Complete Signal Evaluation Forms as needed in order to monitor product performance
  • NCEP/CAPA ownership, particularly proven experience with complex, multi-site problem-solving
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Ensure the development and execution of streamlined business process which help achieve VIP/Continuous Improvement goals.
  • Understanding the steps to End of Life of a Sourced Finished Medical Devices highly desired.
  • Experience with externals standards and regulatory requirements highly desired.
Required Qualifications:
  • Bachelor's degree in computer, electronic or electrical engineering
  • 5+ years of experience in design assurance, post-market quality, or R&D engineering.
  • Experience with electrical test and measurement equipment.
  • Understanding and demonstrated use of IEC 60601 for medical electrical equipment
  • Proficient use of Microsoft Teams, Word, PowerPoint, and Excel
Preferred Qualifications:
  • Experience in design engineering, process development and continuation engineering.
  • Strong communications skills. Effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise.
  • Strong project management skills
  • Experience in post-market quality, including returned product analysis and corrective and preventative action (CAPA).
  • Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls.
Requisition ID: 607321Minimum Salary: $ 82600Maximum Salary: $ 156900The 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