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Principal Design Quality Engineer

Work mode:  Hybrid
Onsite Location(s): 

Maple Grove, MN, US, 55311

Additional Location(s):  N/A

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

About the role: 
We have an exciting opportunity to join the Design Quality team supporting the TheraSphere Y90 device. TheraSphere is a catheter-based, loco-regional radiation therapy approved for the treatment of liver cancer. In addition, it has received FDA Breakthrough Device designation for the treatment of glioblastoma, and the team is investigating safety and efficacy of the therapy for this cancer. This Principal Design Quality Engineer will work with high-performance cross-functional development teams to progress the Human Feasibility Assessment, and ultimately to the program’s strategic, commercial goals while ensuring delivery of the highest quality product to the customer. In this role, you will make important contributions to exciting new applications and excel in a dynamic, fast-paced environment for product development.  

Work mode: 

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

Relocation assistance: 

Relocation assistance is 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.  

Your responsibilities will include: 

  • Leads or mentors the project team in the execution of deliverables such as Design and Development Planning, Risk Management, Design Verification and Validation, Usability Validation plans, Design Review, Design Change, and NCEP/CAPA/PIR  

  • Effectively communicates within project team, across functions, and elevates issues above the project team as appropriate 

  • Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors  

  • Influences cross-functional plans, guides overall project strategy, knows when to solicit feedback, and facilitate project decisions  

  • Understand clinical use cases and user interface requirements to drive design decisions and implement through the risk management package.  

  • Participates as a division representative in cross-divisional projects defining the quality system and may advise management of potential improvements to the quality systems and processes 

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues 

  • Supports functional and divisional design quality goals and priorities   

What we’re looking for in you: 

Required Qualifications: 

  • Bachelor’s degree in an Engineering discipline  

  • 9+ years of experience in design assurance, quality, or related medical device experience; or Master's degree and 7+ years experience.  

  • Knowledgeable in Quality System Regulations, Medical Device Regulation, ISO 13485 and ISO 14971 Quality Standards 

  • Proven use of Quality tools and methodologies 

  • Demonstrated problem-solving, critical thinking, and data analysis capabilities 

  • Hands-on approach to product development and qualification 

  • Ability to collaborate and influence across multiple, cross-functional teams 

  • Strong communication skills (verbal and written) 

Preferred Qualifications: 

  • Comfort with self-directed work in addition to collaboration in a team environment 

  • Experience with clinical trial support, multi-site teams, and contract manufacturers  

  • Self-starter with the ability to identify improvement opportunities 

  • Strong ability to successfully multi-task and adapt 

  • Comfort speaking to groups of individuals. Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences. 

 

Requisition ID: 619538 

Minimum Salary: $ 99100 

Maximum Salary: $ 188300 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—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.  


Nearest Major Market: Minneapolis

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