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Urgent! Senior Design Quality Assurance Engineer Job Opening In Maple Grove – Now Hiring Boston Scientific

Senior Design Quality Assurance Engineer



Job description

About the role:

 
This is an exciting opportunity for a Senior Design Quality Assurance Engineer to join a cross-functional team on the new Renal Denervation business within BSC’s Cardiology division.

This position will support the significant new Renal Denervation acquisition integration and product development program 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 to support acquisition integration of product design, product development lifecycle and software development lifecycle activities.

The Senior Design Assurance Engineer 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.

At Boston Scientific, we value collaboration and synergy.

This role requires employees to be in our Arbor Lakes, MN office four days per week.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include: 

  • Work within a cross-functional, cross-site team to identify and implement effective controls to support product acquisition integration and product development from concept through commercialization.

  • Act as an effective leader or team member in supporting quality disciplines, decisions, and practices, providing quality and compliance input to project teams for project decisions and deliverables throughout total product lifecycle of the medical electrical equipment systems, including hardware, firmware and software.

  • Participate in the implementation of new product design controls including risk management (per ISO 14971) for medical electrical equipment systems, including hardware, firmware and software.


  • Support the execution and documentation of Design Verification, Design Validation, and Usability activities with a thorough understanding of medical electrical equipment, system engineering and software design controls.

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including software bugs and/or field issues.

  • 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.

  • Required qualifications:

  • Bachelor’s degree in Engineering, or related degree

  • Minimum of 5 years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience 

  • Understanding of Medical Electrical Equipment (MEE) Total Product Life Cycle

  • Experience withhardware, firmware and system testing and associated issues investigation/resolution

  • Adaptable and effective collaborator in a team environment and in self-directed work

  • Strong communication skills (verbal & written)

  • Ability to work in a highly matrixed and geographically diverse business environment

  • Demonstrated use of Quality tools/methodologies
  • Preferred qualifications:

  • Prior Software experience

  • Medical device or other regulated industry experience

  • Strong knowledge of Quality System Regulation (QSR, MDR), Risk Management standards (ISO 14971) and Cybersecurity requirements/guidance

  • People management/supervision, coaching, mentoring experience
  • Requisition ID: 614280 


    Minimum Salary: $ 82600 


    Maximum Salary: $ 156900 

    The 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 identity, 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.


    Required Skill Profession

    Engineers



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