Senior Test-Validation Engineer I
Veröffentlicht:
10 September 2024Pensum:
100%Vertrag:
Festanstellung- Arbeitsort:Johnson
Abiomed, Inc. (a member of Johnson & Johnson Family of Companies), is currently seeking a Senior Test Engineer I to join our extraordinary team located in Danvers, MA!
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.
As part of our "Patients First" culture, you will play a crucial role in ensuring our products meet the highest quality standards to save lives and recover hearts!
Key Responsibilities:
- Understand device design and core technologies in order to support platform teams to develop validation strategy.
- Design comprehensive test plan, and create detailed test protocols that ensure they align with design and regulatory requirements.
- Design and Validate test method and associated test fixture/system.
- Conduct risk assessments to identify potential failure modes and their impact on patient safety and device performance.
- Lead investigations into test failures, performing root cause analysis to resolve underlying issues.
- Collaborate with design, development, and quality teams to resolve issues and implement corrective actions.
- Prepare and maintain detailed documentation of test procedures, test fixture work instructions, and SOPs to meet regulatory and quality management system (QMS) requirements.
- Identify opportunities to improve testing processes, methodologies, and tools to enhance efficiency and effectiveness.
- Provide guidance and mentorship to team members, helping to develop their skills and knowledge.
- Work closely with cross-functional teams, including R&D, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration of testing activities.
- Manage testing tools, equipment, and software, ensuring they are calibrated and validated for use.
- Communicate test results, risks, and issues to collaborators, including management, customers, and regulatory bodies, in a clear and concise manner.