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Medical Affairs Group

Field Clinical Engineers(1 of 6)

  • Titel Field Clinical Engineers(1 of 6)
  • Fungsi Medical Affairs Group
  • Sub Fungsi Medical Affairs
  • Location United States; Los Gatos, California, United States
  • Posted
  • ID Permintaan 2306157433W
Melamar Sekarang
Bagi

Deskripsi

Laminar Inc., recently acquired by Johnson & Johnson is hiring for a Field Clinical Engineer. This is a fully remote role.

In this highly visible role, the Field Clinical Engineer is responsible for supporting clinical research investigational 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 Laminar LAAC investigational cases as needed. Developing and maintaining strong knowledge of LAAC, Laminar device, 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 Laminar 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 Laminar 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, Laminar LAAC System, and Laminar clinical investigations.
  • Identifying, remediating, and escalating site compliance issues.
  • Partnering with clinical affairs, other Laminar personnel, and CRO partners to develop effective communication strategies.

Kualifikasi

Job Qualifications:

Required:

·       A minimum of a Bachelor’s degree

  • Minimum 3 years of experience working in clinical research and/or medical device product support in an interventional or electrophysiology environment
  • Experience providing didactic and hands-on training to physicians is required
  • Knowledge of interpreting medical imaging 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.

Preferred :

·       A degree in Biological sciences, engineering, or a health related field

·       Clinical research and/or medical device product support in the cardiac space

  • Regulatory Knowledge: Familiarity with regulatory processes and submissions for medical devices, such as IDE (Investigational Device Exemption), IND (Investigational New Drug), or CE Marking.
  • RCIS, RCES, or ARRT certification

The base pay range for this position is 113,000- 227,000.

 

Working Conditions:

Home-office based and includes approximately 80% travel to research sites, conferences and/or other Laminar affiliated activities. There is the potential for exposure to radiation, blood borne pathogens, and other potentially infectious materials. The employee is frequently required to use a computer and sit for extended periods of time in office. While onsite, the employee will frequently stand for extended periods of time while wearing lead that may weigh more than 10 pounds. Must maintain a clean driver’s license.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

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