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Senior Clinical Research Engineer

External
Becton Dickinson logoBecton Dickinson · - Irvine Laguna Canyon, CA
Full-timeRemote4d ago
Clinical TrialsComplianceData AnalysisDocumentationGCP
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About the role

The Senior Clinical Research Engineer at Becton, Dickinson and Company will lead and execute clinical research activities, focusing on the design, development, and evaluation of innovative medical devices and technologies. This role involves translating clinical needs into technical requirements, supporting clinical trials, and ensuring the scientific rigor and regulatory compliance of our products.

Responsibilities

  • Lead and participate in the design, planning, and execution of clinical research studies for new and existing medical devices, from concept to post-market surveillance.
  • Translate clinical and user needs into detailed technical and system requirements, collaborating closely with R&D, marketing, and regulatory teams.
  • Develop and validate clinical study protocols, case report forms (CRFs), and other study-related documentation in accordance with regulatory guidelines (e.g., GCP, ISO 14155).
  • Perform data analysis, interpretation, and reporting of clinical study results, contributing to scientific publications, regulatory submissions, and internal decision-making.
  • Collaborate with external investigators, clinicians, and key opinion leaders to gather insights, validate designs, and disseminate research findings.
  • Provide technical expertise and clinical input during product development lifecycle, including risk assessment, design reviews, and usability testing.
  • Stay abreast of industry trends, clinical advancements, and regulatory changes relevant to medical device development and clinical research.
  • Mentor junior associates and support cross-functional teams in understanding clinical perspectives and research methodologies.
  • Ensure all clinical research activities adhere to company policies, ethical standards, and applicable local and international regulations.
  • Minimum Experience and Education Required:
  • Bachelor's degree in biomedical engineering, Clinical Engineering, Bioengineering, or a related scientific/technical discipline.
  • At least 5 years of experience in clinical research, medical device development, or a closely related field within the medical device industry.
  • Demonstrated experience in designing, executing, and analyzing clinical studies, including familiarity with different study designs (e.g., feasibility, pivotal, post-market).
  • Strong understanding of medical device regulations (e.g., FDA, EU MDR) and Good Clinical Practice (GCP) guidelines.
  • Excellent written and verbal communication skills, with the ability to effectively present complex clinical and technical information to diverse audiences.
  • Proven ability to work independently, manage multiple projects simultaneously, and meet aggressive deadlines.
  • Strong problem-solving skills and a meticulous attention to detail.
  • Ability to travel domestically and internationally as required (approximately 10-20%).

Requirements

  • Master's Degree
  • Experience working in new product development (NPD)
  • Why Join Us?
  • We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
  • To learn more about BD visit https://bd.com/careers .
  • Becton, Dickinson, and Company is an Equal Opportunity Employer. We eva

Benefits

Health insuranceRemote work options

Additional Information

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description


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