Senior Design Assurance Engineer

Recruiter: Spencer Gregory Hale

 

 

Senior Design Assurance Engineer

 

About the role:
The Senior Design Assurance Engineer directly supports medical device product development from concept through commercialization.  This engineer will serve as a quality representative on a high-performing cross-functional and cross-divisional team for product transfer and 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.
• Learn differences in divisional Quality Systems and Tools and apply them to product development or to design change process.
• 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 for cross divisional product.
• 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. 

 

Minimum qualifications:

• Bachelor’s degree in engineering (or other related technical discipline).
• 5+ 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 electrical, software, or systems engineering.