Senior Test-Validation Engineer I

6 days ago

Danvers, United States Johnson & Johnson Full time
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

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.


Qualifications

Education:
  • Bachelor's 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.

  • Senior Process Engineer II

    4 days ago

    Danvers, Massachusetts, United States The Chemical Engineer Full time

    About the RoleWe are seeking a highly skilled Senior Process Engineer II to join our team at The Chemical Engineer. As a key member of our engineering team, you will be responsible for leading early-stage design and process development projects for novel hemodynamic support devices and accessories.Key ResponsibilitiesLead initiatives with engineers in...

  • Senior Test Engineer

    2 months ago

    Danvers, United States Mondo Full time

    Overview:We are seeking a highly skilled Senior Test Engineer to join our team. This role will focus on end client integrations, ensuring that our testing processes align with their specific rules and regulations. The ideal candidate will spend a significant amount of time in the lab, writing web instructions for different equipment and validating test...

  • Senior Test Engineer

    2 months ago

    Danvers, United States Mondo Full time

    Overview:We are seeking a highly skilled Senior Test Engineer to join our team. This role will focus on end client integrations, ensuring that our testing processes align with their specific rules and regulations. The ideal candidate will spend a significant amount of time in the lab, writing web instructions for different equipment and validating test...

  • Test Method Validation Specialist

    2 weeks ago

    Danvers, Massachusetts, United States HCLTech Full time

    About HCLTech: HCLTech is a leading global technology organization, employing over 223,400 professionals across 60 countries. We specialize in delivering exceptional capabilities in digital transformation, engineering, cloud solutions, and artificial intelligence, supported by a comprehensive range of technology services and products. Our collaborations span...

  • Test Method Validation Specialist

    2 weeks ago

    Danvers, Massachusetts, United States HCLTech Full time

    About HCLTech: HCLTech is a leading global technology organization, employing over 223,400 professionals across 60 countries. We provide top-tier capabilities in digital transformation, engineering, cloud solutions, and artificial intelligence, supported by a comprehensive range of technology services and products. Our collaboration spans various industries,...

  • Validation Engineer

    1 month ago

    Danvers, United States HCLTech Full time

    About us : HCLTech is a global technology company, home to more than 223,400 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial...

  • Test Engineer III

    2 months ago

    Danvers, United States Mondo Full time

    Title: Test Engineer IIILocation: Onsite in Danvers, MADuration: 12+ months with opportunity for hire after 6; includes benefitsStart Date: ASAPRate: Competitive and dependent upon experienceUnfortunately, we cannot work with third party employers or those on STEM visas at this time.As a Test Engineer, you will drive technical efforts, support design...

  • Test Engineer III

    2 months ago

    Danvers, United States Mondo Full time

    Title: Test Engineer IIILocation: Onsite in Danvers, MADuration: 12+ months with opportunity for hire after 6; includes benefitsStart Date: ASAPRate: Competitive and dependent upon experienceUnfortunately, we cannot work with third party employers or those on STEM visas at this time.As a Test Engineer, you will drive technical efforts, support design...

  • Lead Measurement Process Engineer

    2 weeks ago

    Danvers, Massachusetts, United States The Chemical Engineer Full time

    The Chemical Engineer is seeking a Senior Process Development Engineer specializing in measurement techniques.This position is essential for the advancement of our innovative engineering solutions, focusing on the precise measurement of components made from metals, ceramics, and plastics.This role represents a significant opportunity for a professional to...

  • Sr Eng Process Engineering- Electronics

    2 hours ago

    Danvers, United States Johnson & Johnson Full time

    Description Abiomed, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Senior Supplier Engineer, to be 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...

  • Test Development Specialist

    2 days ago

    Danvers, Massachusetts, United States Oceanic Enterprises Full time

    Job DescriptionAt Oceanic Enterprises, we are seeking a highly skilled Test Engineer to join our team. As a key member of our organization, you will play a critical role in ensuring the quality and reliability of our products.Key Responsibilities:Test Planning and Execution: Develop and execute comprehensive test plans to validate the performance and...

  • Product Development Engineer I

    1 month ago

    Danvers, Massachusetts, United States Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Product Development Engineer I to join Abiomed's surgical engineering platform based in Danvers, MA. Key Responsibilities:Build and innovate current medical, technical, and biomedical developments related to company products and heart recovery technologies. Work towards leading product development improvement efforts...

  • Product Development Engineer I

    1 month ago

    Danvers, United States Johnson & Johnson Full time

    Description Johnson & Johnson is currently seeking a Product Development Engineer I to join Abiomed's surgical engineering platform based in Danvers, MA. Key Responsibilities: Build and innovate current medical, technical, and biomedical developments related to company products and heart recovery technologies. Work towards leading product development...

  • Fabrication & Test Technician

    2 months ago

    Danvers, United States Lighthouse Professional Services Full time

    Job DescriptionJob DescriptionLighthouse Professional Services, a division of Staffing 360 Solutions group of companies, has been providing contract and direct hire talent to client companies, ranging from small businesses to Fortune 500 corporations for over 50 years. Our offices are in New York, Connecticut, and Massachusetts, and we work with clients...

  • Senior RF

    3 months ago

    Danvers, United States Crane Aerospace & Electronics Full time

    **Senior RF (Radio Frequency) Engineer** Location **MA, Danvers** Department **Engineering** Employment Type **Full Time** **Crane Aerospace and Electronics** has an exciting opportunity fora **Senior Radio Frequency (RF) Engineer (Level IV)** at our Danvers, MA location. **About Crane:** **Crane Aerospace & Electronics** supplies critical systems and...

  • Senior Plastics Engineer

    1 week ago

    Danvers, Massachusetts, United States Merck KGaA Full time

    About the RoleThe Senior Plastics Engineer will play a key role in the Product Engineering Team, supporting the development of Mobius Single Use products across our global network of manufacturing sites. This is a unique opportunity for a collaborative and innovative individual to join our team and contribute to the growth of our rapidly expanding product...

  • Senior Industrial Engineer

    1 week ago

    Danvers, United States Boston Industrial Consulting, Inc. Full time

    Senior Industrial Engineer Our consulting practice works with industry leaders on projects in Lean Manufacturing, Factory Workflow, Automation, Robotics and Optimization of Manufacturing and Supply Chain operations. As a Senior IE on our team, you will be working on high exposure projects with senior level executives. You will learn every day from our...

  • Engineering Technician

    1 month ago

    Danvers, Massachusetts, United States Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Optical Engineering Technician to join our 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...

  • Senior Electrical Engineer for Medical Imaging Systems

    2 weeks ago

    Danvers, Massachusetts, United States Neurologica Full time

    WHO WE ARE: NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., specializes in the development, manufacturing, and marketing of cutting-edge imaging technologies. Our mission is to provide rapid, straightforward, and precise diagnostic solutions to healthcare providers.As the global headquarters for mobile computed tomography, NeuroLogica also...

  • Sr. Plastics Engineer

    2 weeks ago

    Danvers, United States Merck KGaA Full time

    Work Location:Danvers, Massachusetts Shift: Department:LS-SC-WSAB US Danvers Mobius Product Eng Recruiter: Carolyn Angle Jones This information is for internals only. Please do not share outside of the organization. Your Role: The Senior Plastics Engineer is a key resource within the Product Engineering Team in the support of Mobius Single Use products that...