Senior Engineer, Quality Engineering Lifecycle Management
Johnson & Johnson is seeking a Senior Engineer with exceptional problem-solving and analytical skills to join our Quality Engineering Lifecycle Management team in Irvine, CA!
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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
In this role you will represent the Quality Engineering function for marketed product and the state of quality and compliance throughout the product’s life cycle. You will ensure sustaining engineering projects are conducted in compliance with internal, customer, and regulatory requirements!
This is a unique opportunity to contribute to a world-class organization that is committed to improving health outcomes and transforming the future of healthcare. If you are ready to make a significant impact in the field of healthcare and join a global leader in innovation, we encourage you to apply now!
Key Responsibilities:
- Design Quality team member focused on lifecycle management activities associated with Neurovascular products.
- Ensure compliance to Medical Device regulations and standards, including Design Control Regulatory requirements, in worldwide markets for product design and supplier changes.
- Lead and educate other teams within the organization on medical device regulations.
- Collaborate with the lifecycle management team to guide the application of design change controls and risk management, while assessing the effect of changes on design input, design outputs, failure modes, test methods, and design verification and validation activities.
- Support internal and external regulatory compliance audits and drive continuous improvement in quality systems execution across the company.
- Monitor the risk management process to ensure devices continue to meet intended safety and performance standards.
- Evaluate and update inspection methodology, acceptance criteria, and transfer functions for products and components associated with design changes post-product launch.
- Participate in component and service supplier evaluation to maintain high quality standards.
- Provides statistical support and analytical problem solving.
