Senior Principal Quality Engineer – Design Quality & Systems Excellence

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

About MedTech

 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. Learn more at https://www.jnj.com/medtech

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.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/.  

 

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

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