Senior Clinical Research Engineer
$129,600–$207,400 year
On-site · Irvine, California, United States
Job Summary
Lead and execute clinical research activities for new and existing medical devices from concept through post-market surveillance, translating clinical and user needs into technical and system requirements. Develop and validate clinical study protocols and CRFs aligned with regulatory guidelines (GCP, ISO 14155). Perform data analysis and contribute to regulatory submissions, publications, and internal decision-making. Collaborate with R&D, regulatory, and external investigators to validate designs, conduct usability testing, perform risk assessments, and participate in product development lifecycle. Mentor junior staff and ensure adherence to company policies and applicable local and international regulations. Requires travel domestically and internationally (approximately 10-20%) and on-site collaboration with a minimum of four days in the office per week at the Irvine, California location.
Required Qualifications
- Bachelor's degree in biomedical engineering, Clinical Engineering, Bioengineering, or related scientific/technical discipline
- At least 5 years of experience in clinical research, medical device development, or closely related field
- Demonstrated experience in designing, executing, and analyzing clinical studies (feasibility, pivotal, post-market)
- Strong understanding of medical device regulations (FDA, EU MDR) and Good Clinical Practice (GCP) guidelines
- Excellent written and verbal communication skills for diverse audiences
- Ability to work independently, manage multiple projects, and meet deadlines
- Willingness to travel domestically and internationally (approximately 10-20%)
- Preferred Master's degree and experience in new product development (NPD)
- On-site collaboration with requirement for in-office presence (minimum 4 days per week as indicated in job posting)
Additional Requirements
- None specified
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