Senior Design Assurance Engineer

About This Role

This Senior Design Assurance Engineer supports medical device product development from concept through commercialization and sustainment within the Cardiac Rhythm Management and Diagnostics division. The role involves various quality-related activities, focusing on high-visibility issues impacting product performance and requires collaboration with cross-functional teams to achieve optimal results.

Responsibilities

• Understand and apply design engineering concepts and tools including DFMEA, Design Verification & Validation, Benchmarking, Test Method Validation, and Design Transfer
• Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues, including CAPA work
• Review and approve quality records, including product specifications, design verification test protocols, and design verification test reports
• Lead or contribute to collaborative problem solving of complex technical issues using disciplined, methodical techniques (e.g., DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagram, Is-Is Not)
• Create, maintain, and enhance cross-functional team partnerships; provide guidance on technical strategies and approach
• Focus on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations
• Monitor and ensure compliance with company policies and procedures
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

Requirements

• Bachelors degree in an engineering or related discipline
• 5+ years of relevant experience
• Experience in Medical Device industry
• Knowledgeable in Quality System Regulations, Medical Device Regulation, ISO 14971 and ISO 13485 Quality Standards with a focus on design controls and design optimization
• Proficient with Microsoft Office tools
• Ability to collaborate and influence across multiple, cross-functional teams
• Demonstrated technical problem-solving & data analysis capabilities

Qualifications

• Bachelors degree in an engineering or related discipline
• 5+ years of relevant experience

Nice to Have

• Experience in design engineering or process development, including test method validation, process validation, and continuation engineering
• 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
• Experience in post-market quality, including returned product analysis and corrective and preventative action (CAPA)
• 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
• Strong ability to successfully multi-task and demonstrate adaptability
• Strong communications skills

Skills

* Required skills