Senior Manager, Field Clinical Engineering | Sunnyvale, CA

In this key customer facing position, the Field Clinical Engineering Manager will lead by example by demonstrating technical expertise, business acumen, and will uphold the ethical principles of clinical research and patient care. Job Description Recruiting, training, managing, and motivating a team of field clinical engineers to provide onsite case support for Laminar LAAC investigational cases.

Supporting Laminar LAAC investigational cases as needed. Developing and maintaining strong knowledge of LAAC, Laminar device, and competitive landscape. Developing and 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. 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. Creating and implementing processes for 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.

Driving the creation and distribution of 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. Planning, budgeting, and tracking of employee expenses.

Job Qualifications: Education: Bachelor's degree required, with a major in Biological sciences, engineering, or a health related field and RCIS, RCES, or ARRT certification preferred. Minimum 5 years of experience working in clinical research and/or medical device product support in an interventional or electrophysiology environment. Minimum 2 years of people management experience. Inspires a strong sense of collaboration and teamwork throughout the field organization. Fosters the growth and development of each team member. Proficient in sterile preparation and functioning in the catheterization / EP lab environment.

Familiarity with clinical research methodologies and practices and adherence to US and international 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). Regulatory Knowledge: Familiarity with regulatory processes and submissions for medical devices, such as IDE (Investigational Device Exemption), IND (Investigational New Drug), or CE Marking.

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.

Leadership and Project Management: Demonstrated ability to lead and manage field-based teams in medical device development, including resource allocation, timelines, budgeting, and coordination of team members. Ethical Standards: Commitment to maintaining ethical standards in clinical research, including patient privacy, informed consent, and protection of human subjects. Continuous Learning: Willingness to stay updated with the latest advancements, regulations, and industry best practices in clinical research and medical device technologies. Other/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, interaction, interactionual 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..