Senior Clinical Research Engineer

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.

• 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 the 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.

• 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%).

• Master’s degree.
• Experience working in new product development (NPD).

Primary

Work Location:

Irvine, CA (Laguna Canyon). Salary range: $ – $ USD annually.

Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.