Design Assurance Engineer III

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: 
The Design Assurance Engineer III directly supports medical device product development from concept through commercialization.  This engineer will serve as a quality representative on a high-performing cross-functional team for product development on a major product category. This high visibility position provides the right candidate with excellent growth and development potential. 

 Your responsibilities will include: 

• Understanding and application of design engineering concepts and tools including Design Failure Modes and Effects Analysis (DFMEA), Design Verification & Validation, Benchmarking, Test Method Validation, and Design Transfer. 

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

• Serve as an effective quality leader or team member on a cross-functional product development team. 

• Owns and drives deliverables related to Design Controls, Product Performance, Quality, and Compliance. 

• Develops and implements quality strategies; seeks innovative approaches to attain quality goals. 

• Review and approve quality records, including product specifications, design verification test protocols, and design verification test reports.  

• Maintains and enhances cross-functional team relationships.  

• Directly interfaces with internal and external audit activities.  

What we're looking for in you: 

Required Qualifications 

• Bachelor’s degree in engineering (or other related technical discipline). 

• Minimum 3 years of experience in design assurance, post-market quality, or R&D engineering.  

• Strong mechanical and electrical aptitude. 

• Experience writing specifications, test protocols, and technical reports. 

• Demonstrated use of Quality tools and methodologies including DFMEA, DOE, Brainstorming, Root Cause Analysis, and 5 Why’s.  

• Demonstrated ability to solve complex engineering problems using analysis, experimentation, and statistics. 

• Experience with mechanical and electrical test and measurement equipment. 

• Strong communications skills. Effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise. 

• Proficient use of Microsoft Teams, Word, PowerPoint, and Excel 

Preferred Qualifications: 

• Bachelor’s degree in mechanical engineering. 

• Experience in design engineering or process development, including test method validation, process validation, and continuation engineering. 

• Experience in post-market quality, including returned product analysis and corrective and preventative action (CAPA). 

• Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization. 

• Experience with Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD).