Design Quality Engineer II

Recruiter: Spencer Gregory Hale

 

 

Design Quality Engineer II (Hybrid) 

 

About the role:   
This position will work on the Cortex Integration project, specifically supporting Design Control 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 Assurance Quality Engineer II directly supports medical device product development from concept through commercialization.   

To learn more about Design Assurance Engineering at Boston Scientific, please check out our DA Day in the Life Series session. 
  

Your responsibilities will include: 

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

• Acts as an effective team member in supporting quality disciplines, decisions, and practices 

• Work within a cross-functional team to identify and implement effective controls and support integration of design control related products, records, and processes 

• Write various technical documentation for procedure execution, technical rationale, and evidence of the development process. 

• Support Design Assurance activities as related to Design Control Quality System integration, and other DA related integration priorities 

• Support Post Market activities, as necessary, of risk based on post-market signals, field assessments 

• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed 

• Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards. 

• 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) 

• 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 we’re looking for in you: 
Minimum qualifications: 

• Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline) 

• 2+ years of experience in design assurance, new product development or related medical device/regulated industry experience 

• Self-motivated with a passion for solving problems and a bias for action 

• Hands-on approach to product development 

• Strong communication skills (verbal & written) 

• Demonstrated use of Quality tools/methodologies. 

• Ability to effectively work and collaborate in a mixed onsite + remote environment. 

• Demonstrated experience making oral presentations to a wide variety of stakeholders and creating detailed technical documents  

 

Preferred qualifications: 

• Quality Integration experience 

• ISO 13485, ISO 14971 and Quality System