Principal Design Quality Engineer - WATCHMAN

bostonscientific•Maple Grove, MN

1d•$102,100 - $194,000•Hybrid

About The Position

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 for a Principal Design Quality Engineer supporting WATCHMAN new product development projects within BSC’s Cardiology division. WATCHMAN continues to be an exciting growth driver for BSC. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential, new product development experience, and exposure to first in human studies. The Design Quality Principal Engineer will lead a team of engineers and technicians to apply the directives of design controls during product development. Work mode: At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Maple Grove, MN, Weaver Lake Campus and requires at least three days per week on-site.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or related Engineering field of study
Minimum of 8 years of experience in design assurance, quality, or related medical device or regulated industry experience
Experience in new product development: e.g. driving and creating risk management deliverables (risk management plan/report, hazard analysis, task analysis, dfmea, etc.), validating test methods, supporting the creation of design requirements, design verification and validation
ISO 13485, ISO 14971, CFRs, and Quality System Regulations understanding & demonstrated use
Excellent organizational and planning skills; drives for results
Strong communication skills (verbal & written)
Demonstrated use of Quality tools/methodologies
Ability to travel up to 10%

Nice To Haves

Experience in developing test methods
Experience supporting clinical trials
Problem solver, capable of facilitating the problem-solving process
Adaptable and effective collaborator in a team environment and in self-directed work
Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups.
Experience with Class III Medical Devices

Responsibilities

In-depth understanding and application of Design Control and Risk Management concepts.
Provide quality and compliance input to project teams.
Support the execution and documentation of Design Validation & Verification and Usability activities.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification and Component Specifications).
Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
Lead and support cross-functional root-cause analysis investigation and resolution activities
Support regulatory submissions to notified bodies.
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.