Design Quality Engineer II

bostonscientific • Valencia, MN

1d • 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: This position will work on the EP/CRM Integration projects, specifically supporting Design Controls under the direction of the Design Control Workstream lead. This position ensures that during the integration of products and Design Control quality system processes, the product and processes remain safe, of high quality, and compliant with regulatory requirements. The Design Quality Engineer II directly supports medical device product development from concept through commercialization. Work Mode: This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Candidates can be based out of the following locations: Arden Hills, Maple Grove, Valencia, Waltham, Marlborough, Spencer, or Mississsauga Visa Sponsorship: Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation: This role will not provide relocation support or assistance.

Requirements

• Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline)
• Minimum of 2 years of experience in Quality design assurance, new product development or related medical device/regulated industry experience
• Ability to travel up to 10%

Nice To Haves

• Quality Integration experience
• ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Boston Scientific experience
• Ability to effectively work and collaborate in a mixed onsite + remote environment.

Responsibilities

• 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 integration of design control related products, records, and processes
• Support the verification, validation, and usability testing to meet or exceed internal and external requirements
• Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
• Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)
• Support Design Assurance (DA) activities as related to Design Control Quality System integration, and other DA related integration priorities
• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Partner cross-functionally to identify and support value improvement efforts to support business goals

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees