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Design Quality Engineer II
Design Quality Engineer IIbostonscientific • Minnetonka, Minnesota, USA
Design Quality Engineer II

Design Quality Engineer II

bostonscientific • Minnetonka, Minnesota, USA
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Additional Location(s) : N / A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role :

Boston Scientific Urology division has an opportunity for a Design Quality Engineer II to join our prosthetic Urology. team. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential and product development / sustaining experience. Design Quality Engineer II will work cross-functionally to ensure safety performance and compliance of our device while delivering the highest quality product to the customer. This role will serve as a Quality team member on New Product development (NPD) Sustaining and / or Integration projects and will utilize quality engineering methodologies and practices which meet BSC customer and regulatory requirements.

Work mode :

At Boston Scientific we value collaboration and synergy. This hybrid role is based in Minnetonka MN and requires being on-site at least three days per week.

Relocation assistance :

Relocation assistance is not available for this position at this time.

Visa sponsorship :

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

This position will start off at our Minnetonka MN facility but will be transferred to our Weaver Lake campus Maple Grove MN facility in 2026.

Your responsibilities will include :

  • Be a part of an extended project team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
  • Develops understanding of Design Controls Risk Management and Usability for Medical Devices.
  • Applies sound systematic problem-solving methodologies in identifying prioritizing communicating and resolving quality issues.
  • Supports departmental functional and divisional design quality goals and priorities.
  • Executes methodologies to effectively meet individual and team objectives.
  • Utilizes methodologies such as Statistical Analysis Risk Management and Root Cause Analysis in support of project activities.
  • Ensures adherence to the quality system Policies SOPs and work instructions following Boston Scientifics Product Life Cycle Process (PLCP).

Required qualifications :

  • Bachelor of Science in Mechanical / Biomedical Engineering or related discipline in the sciences.
  • Minimum of 2 yearsexperience inDesign Quality Assurance related experience in quality engineering or NPD design within a regulated industry
  • Experience with medical device development for single use devices
  • Working knowledge of key regulatory requirements including ISO 14791 (Risk Management) 21 CFR(US QS Regulation) ISO 13485 (Quality Management Systems) EU MDR and IEC 62366-1 (Usability).
  • Understanding of Quality tools and methodologies with an emphasis on Design Controls Root Cause Analysis and Risk Management.
  • Strong communication skills (verbal & written)
  • Ability to work independently and as part of a team.
  • Ability to travel up to 10%.
  • Comfortable with complaint data reviews and interpretation
  • Preferred qualifications :

  • Experience with pharmaceutical or combination medical device development
  • Experience with Electronic Medical Equipment.
  • Requisition ID : 617156

    Minimum Salary : $69500

    Maximum Salary : $132000

    The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see 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) isnt just business its personal. And if youre 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 Companys policies or protocols change with regard to COVID-19 vaccination.

    Among other requirements Boston Scientific maintains specificprohibited substancetest 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.

    Key Skills

    Mechanical Design,SOC,System Design,GD&T,CAD,Creo,SolidWorks,Mechanical Engineering,Perl,Autocad,HVAC Design,Catia

    Employment Type : Full Time

    Experience : years

    Vacancy : 1

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