Field Clinical Engineer

I am hring for Field Clinical Engineer. This remote position will be based in Europe, with significant travel required within the EU. For further information about this position please apply and share with your network!

In this highly visible role, the Field Clinical Engineer is responsible for supporting clinical research investigation cases in the area of left atrial appendage closure. In this key customer facing position, the Field Clinical Engineer will demonstrate technical expertise, business acumen, and will uphold the ethical principles of clinical research and patient care.

Job Description

• Supporting LAAC investigation cases as needed. Developing and maintaining strong knowledge of LAAC and competitive landscape.
• Implementing effective training programs for physicians and catheterization / EP lab staff.
• Assisting catheterization / EP lab and research staff in the recording of essential data points during Laminar LAAC procedures.
• Sterile preparation of devices in the catheterization / EP lab environment.
• Providing didactic and hands-on training to physicians and catheterization / EP lab staff on the LAAC device and procedure.
• Interpreting medical imaging studies (echo, fluoroscopy, cardiac CT) to aid in case planning, device selection, and follow-up.
• Being a resource to key stakeholders, including investigators and healthcare professionals to facilitate study enrollment, address inquiries, and maintain effective communication.
• Gathering site feedback on potential LAAC system and procedural refinements and communicating this information to internal Laminar teams.
• Understanding referral pathways and demonstrating the ability to aid clinical sites in identifying potential opportunities to increase clinical trial enrollment and retention.
• Distributing physician and patient-focused literature and other materials to increase awareness and understanding of the left atrial appendage closure and clinical investigations.
• Identifying, remediating, and escalating site compliance issues.
• Partnering with clinical affairs, other personnel, and CRO partners to develop effective communication strategies.
  

Desired Skills and Experience

Job Qualifications:
Required:
* Minimum 3 years of experience working in clinical research and/or medical device product support in an interventional or electrophysiology environment
* A minimum of a Bachelor's degree AND/OR a minimum of 6 years of work experience
* Experience in providing didactic and hands-on training to physicians is required
* Knowledge of interpreting medical imaging such as fluoroscopic image and transesophageal echo image is required
* 80% travel required
* Familiarity with clinical research methodologies and practices and adherence to US regulatory guidelines (i.e., 21 CFR Parts 11, 50, 54, 56, 812 and ISO 14155).
* Able to interpret, summarize, and communicate complex medical literature to internal and external customers.
* Medical Device Experience: Proficient understanding of medical device technologies, their development process, and regulatory requirements specific to medical devices, such as ISO 13485, FDA 510(k), or PMA (Pre-Market Approval).
* Critical Thinking and Problem-Solving: Ability to analyze complex medical and scientific information, identify potential issues or risks, and develop practical solutions.
* Communication and Collaboration: Excellent written and verbal communication skills to effectively communicate with cross-functional teams, investigators, regulatory authorities, and other stakeholders. Strong collaboration skills to work effectively in multidisciplinary teams.
* Ethical Standards: Commitment to maintaining ethical standards in clinical research, including patient privacy, informed consent, and protection of human subjects.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.