Description:
Our client is a growing medical device company specializing in steerable cardiac catheters building a team of Senior Field Clinical Engineers. Operating within Clinical Development & Science in Clinical Affairs and collaborating with Clinical Operations, Medical Affairs, R&D, and Regulatory & Quality Affairs in a cross-functional setting, the Senior Field Clinical Engineer will support the development, management, and execution of investigational and post-market clinical studies.
We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $80.00 to $70.00/hr. w2
Job Number #: JN -072026-107690
Responsibilities
- Serve as the clinical and device technical expert partnering with investigators and study site personnel to ensure high quality clinical cases in compliance with protocol, GCP, IFU, and industry standards.
- Collaborate with Clinical Operations to support study conduct at sites in compliance with protocol, SOPs, regional regulations, and GCP.
- Support study site personnel training on clinical and technical use of the study device per protocol and IFU.
- Collaborate with Clinical Operations on device accountability, including shipment, tracking, and disposition at study sites.
- Manage site communication for case scheduling.
- Collaborate with Clinical Operations on clinical study data compliance at study sites.
- Collaborate with R&D on product development, pre-clinical evaluation, and clinical development of investigational devices.
- Collaborate with Clinical Scientists on protocol development to ensure alignment with clinical practice and device use.
- Collaborate with Regulatory and Quality Affairs on evaluation of device observations, engineering reviews, and post-market product complaints.
Experience Requirements
- 3 to 5 years of experience supporting electrophysiology cardiac ablation cases.
- 2 or more years supporting investigational and post-market clinical studies.
- Positive relationships with study sites supporting EP clinical studies in the United States and/or European Union.
- Working knowledge of GCP for clinical trials.
- Ability to work in a fast paced dynamic setting.
- Ability to lift objects under 30 kg.
- Excellent interpersonal, organizational, and critical thinking skills; able to interface with key opinion leaders in electrophysiology.
- Positive, self-motivated, creative, detail-oriented team player.
- Willingness to travel up to 80% domestically and 20% internationally.