Design Assurance Engineer III - Cardiology

Boston Scientific • Arden Hills, MN

6d • $78,300 - $148,800 • Hybrid

About The Position

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.

Requirements

• 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

Nice To Haves

• 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).
• Adaptable and effective collaborator in a team environment or in self-directed work.

Responsibilities

• 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.

Benefits

• Relocation assistance is not available for this position.
• Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level