Senior Design Quality Engineer - Axonics Integration

Additional Location(s): US-CA-Irvine; US-CA-Valencia; US-IN-Spencer; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove

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:

This position will work on the Axonics Integration project, specifically supporting product Design Control integration 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 BSC and regulatory requirements. 

 

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 Risk Management remediation, Design Control Quality System integration, and other DA related integration priorities 
• Support Post Market activities, as necessary, of risk based on post-market signals 
• 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: 

Required qualifications: 

• Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline) 
• 5+ 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 
• 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 creating detailed technical documents  

Preferred qualifications: 

• Experience working with medical electrical equipment and/or active implantables 
• Quality Integration experience