Senior Principal Quality Engineer – Design Quality & Systems Excellence

Senior Principal Quality Engineer – Design Quality & Systems Excellence

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

We are searching for the best talent for Senior Principal Quality Engineer – Design Quality & Systems Excellence role to be located at Danvers, MA.

ABIOMED is redefining team-driven success while reshaping heart recovery. Here, new ideas are welcomed and encouraged, learning is constant, and our dynamic setting enables positive people to do profoundly important work.

Position Summary

We are seeking a Senior Principal Quality Engineer to serve as a technical leader and change agent driving design quality excellence across complex electro-mechanical, software-driven medical devices.

This role partners deeply with engineering and design quality engineering to ensure robust product design through strong system engineering principles, design controls, and risk management integration. The ideal candidate will lead high-impact, cross-functional initiatives to improve product reliability and robustness through reliability growth programs, design-for portability (ambulation and transport), robust algorithm and sensor system validation, motor control verification and end-to end connectivity.

The successful candidate will work as part of a product development team to translate system architecture, interfaces and trade-offs into robust and verifiable designs, as well as providing system-level design documentation, and ensuring overall product quality across the New Product Development (NPD) and marketed lifecycle.

Key Responsibilities

• Lead design quality strategy across NPD programs, ensuring products are robust, reliable, and compliant
• Serve as the primary quality partner on product development teams, embedding quality-by-design principles from concept through commercialization and ensuring requirements traceability and design control compliance specifically for key Impella console features (reliability growth, portability, usability, algorithms/sensors, motor control, connectivity)
• Establish and deploy a Product Reliability Program (DfR, reliability modeling, growth strategies). This would include accelerated life testing, development of growth curves, statistical reliability demonstration, and test to failure strategies. Use field and verification data to prioritize focus and design changes
• Drive improvement of system-level design documentation, including architecture, interfaces, and functional specifications in collaboration with systems engineering to ensure clear verification responsibility, testability and traceability for multi-domain features (mechanical, electrical, software, algorithms, usability)
• Ensure excellence in design controls (design inputs/outputs, reviews, V&V, design transfer)
• Lead and integrate risk management activities (hazard analysis, FMEA, risk controls)
• Drive product quality improvement initiatives using field data, CAPA, and root cause analysis. Lead cross-functional failure investigations, ensure timely corrective actions, and verify effectiveness
• Partner with Engineering and Quality teams to align on requirements, design intent, and verification strategies. Provide hands-on guidance on appropriate testing scenarios. Influence requirements definition to ensure they are measurable and verifiable
• Partner and collaborate with cross-functional teams to implement improvements and ensure adherence to regulatory standards, impacting operational efficiency and product quality.
• Apply advanced statistical methods to support sampling strategies, reliability demonstration, and data-driven decisions. Define risk-based sampling strategies including verification and reliability demonstration, and apply techniques to support acceptance decisions
• Act as a change agent, driving cross-functional alignment and adoption of best practices
• Provide hands-on technical guidance to develop robust, fault-tolerant system designs.
• Solve technical problems and provide solutions that are technically sound and…