Principal Design Quality Engineer

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, c