Job Information
J&J Family of Companies Senior Test-Validation Engineer I in Danvers, United States
Senior Test-Validation Engineer I - 2406209258W
Description
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 worlds 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.
Qualifications
Education:
- Bachelors degree or University equivalent in Engineering, or STEM (Science, Technology, Engineering, Math) related field.
Experience and Skills:
Required:
A minimum of five (5) years of practical experience in the field of test method validation in a laboratory environment.
Strong engineering background and understanding of engineering principles.
Working experience with statistical analysis and application software (e.g. Minitab).
Experience with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and relevant international regulations.
Proficiency in using test equipment (e.g., Universal test machine, multimeters, pressure sensors, and environmental chambers).
Experience with tools like LabVIEW, MATLAB, or other data analysis and simulation software.
Ability to stay organized, pays attention to important details, and effectively handles multiple tasks and priorities.
Strong written and verbal communication skills for clear documentation and reporting of results.
Problem-solving skills to address issues identified during testing.
Keen attention to detail when designing, executing, and analyzing tests.
Ability to spot discrepancies and ensure that all testing adheres strictly to protocol.
Preferred:
Familiarity with risk analysis processes and tools like Failure Mode and Effects Analysis (FMEA).
Awareness of the entire product lifecycle, from design to post-market surveillance.
Six Sigma or Lean Manufacturing certification for process improvement.
Knowledge of coding or scripting (e.g., Python, C ) for automated testing can be beneficial.
This position will be located in Danvers, MA and may require up to 10% domestic or international travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com (https://jnjc.taleo.net/enterprise/www.careers.jnj.com) .
Primary Location NA-US-4887-Danvers
Organization ABIOMED Inc.(6942)
Travel Yes, 10 % of the Time
Job Function Quality Assurance
Req ID: 2406209258W