Field Procedural Specialist
Company: Orchestra BioMed
Location: Bakersfield
Posted on: January 30, 2026
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Job Description:
Job Description About Orchestra BioMed Orchestra BioMed is a
biomedical innovation company accelerating high-impact technologies
to patients through strategic collaborations with market- leading
global medical device companies. The Company’s two flagship product
candidates - Atrioventricular Interval Modulation (AVIM) Therapy
and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) - are
currently undergoing pivotal clinical trials for their lead
indications which both represent multi-billion-dollar annual global
market opportunities. AVIM Therapy is a bioelectronic treatment for
hypertension, the leading risk factor for death worldwide, and is
designed to be delivered as a firmware upgrade to a pacemaker and
achieve immediate, substantial, and sustained reductions in blood
pressure in patients with hypertensive heart disease. The Company
has a strategic collaboration with Medtronic for the development
and commercialization of AVIM Therapy for the treatment of
uncontrolled hypertension in pacemaker-indicated patients. AVIM
Therapy has FDA Breakthrough Device Designation for these patients
as well as an estimated 7.7 million total patients in the U.S. with
uncontrolled hypertension despite medical therapy and increased
cardiovascular risk. Virtue SAB is a highly differentiated,
first-of-its-kind drug delivery angioplasty balloon system designed
to deliver a proprietary extended-release formulation of sirolimus,
SirolimusEFR™, for the treatment of atherosclerotic artery disease,
the leading cause of mortality worldwide. Virtue SAB has been
granted Breakthrough Device Designation by the FDA for the
treatment of coronary ISR, coronary small vessel disease and
below-the-knee peripheral artery disease. The Company has a right
of first refusal agreement with Terumo Corporation and Terumo
Medical Corporation, a leading global medical device company, for a
potential transaction related to Virtue SAB for the treatment of
coronary artery disease. For further information about Orchestra
BioMed, please visit www.orchestrabiomed.com, and follow us on
LinkedIn. Job Summary Field Procedural Specialist supports and
manages critical trial activities in the field as needed. This
individual will be actively involved in identifying potential study
centers and building relationships with existing centers,
encouraging them to recruit and enroll patients in our study. This
person will provide direct technical support to the centers during
surgical procedures. Currently, this will include the studies in
our Virtue program but may expand as future studies as appropriate.
This key role will be remote and will have significant travel. Role
and Responsibilities – Including but not limited to: Identify and
manage potential study centers to recruit and enroll patients.
Provide direct support and guidance during technical procedures in
OR. Plan, coordinate, and complete each project on schedule.
Operate and maintain study related equipment in accordance with
establish policies and procedures such as Ambulatory and Office
blood pressure equipment. Assist in completion of documentation in
case record forms during clinical trials, as needed. Keeps track
and support site performance in terms of patient recruitment and
timely response to the company's requests. Maintains documentation
regarding any product-related issues. Trains medical staff on
device related equipment and serves as the first point of contact
for any technical questions from the medical team. Coordinate
scheduling and placement of per diem FCE’s in assign territory.
Road Warrior level travel required (over 60%). Please note this job
description is not designed to cover or contain a comprehensive
listing of activities, duties, or responsibilities that are
required of an employee for this job. Duties, responsibilities, and
activities may change at any time with or without notice. Actual
Title, FCE, Sr FCE, Principal FCE will be determined based on
experience. Qualifications – Knowledge & Skills: Minimum bachelor’s
degree in nursing, biomedical or other relevant scientific
discipline. 5 years of related experience working and/or training
in Cath Labs; scrubbing in cases. Experience and/or knowledge of
the management of clinical research processes for interventional
medical device trials in interventional cardiology trials
(experience strongly preferred). Good technical skills and
excellent computer operating skills including Microsoft office.
Excellent presentation skills in a requirement. Cardiovascular
anatomy is required. Demonstrated ability to work well in a
collaborative and dynamic team environment, set priorities, and
drive results. Proven experience in critically reviewing detailed
scientific information and assessing whether technical arguments
are presented clearly, and conclusions are adequately supported by
data. Demonstrated superior oral and written communication skills
and ability to communicate complex issues in a succinct and logical
manner. In-depth knowledge of Good Clinical Practice (GCP) and
Clinical investigations of medical devices for human subjects (ISO
14155) Familiarity with the standards set forth in ISO 14155.
Strong interpersonal skills and ability to collaborate effectively
with various technical area experts. Demonstrated flexibility in
responding to changing priorities or dealing with unexpected
events. Demonstrated effective communication, interpersonal and
negotiating skills. Analytical thinking - systematic gathering,
organization and synthesizing of relevant information. Results
achievement - ability to identify and respond quickly to
opportunities and difficulties, or to take action to accomplish
including organizing future intended action. Knowledge-
Industry/Business/Clinical - knowledge and understanding of the
business, its vision, mission, strategies, products, procedures,
and services as well as of the trends impacting the medical device
industry. Strongly goal-oriented and highly motivated with a high
energy level. A current US work authorization is required. The
above statements are intended to describe the general nature and
level of work being performed by people assigned to this job. They
are not to be construed as an exhaustive list of all
responsibilities, duties, and skills required of personnel so
classified. The level of this position will be based on the final
candidate’s qualifications. All personnel may be required to
perform duties outside of their normal responsibilities from time
to time, as needed. EQUAL OPPORTUNITY EMPLOYER Orchestra BioMed is
committed to non-discrimination with respect to race, creed, color,
religion, age, disability, sex, sexual orientation, gender identity
and expression, marital status, national origin, political opinions
or affiliations, genetic information, and veteran status in all
aspects of employment including recruitment, hiring, promotions,
transfers, discipline, terminations, wage and salary
administration, benefits, and training. Orchestra BioMed has a
multi-part and competitive compensation structure: Competitive base
salary based on experience. Annual bonus based on exceptional
company and individual performance. Equity grants appropriate for
role. We offer a comprehensive and competitive benefits package
which includes health, dental, and vision, 401k as well as other
benefits. Our Vision To be a leader in bringing high impact medical
innovations to life through risk-reward sharing partnerships. Our
Mission We will work passionately to apply our collaboration-based
business model to bring high-impact medical innovations to live and
create extraordinary value for patients, care providers, partners,
and stakeholders. Our Values We care about patients, physicians,
partners, and each other. We are creative , open-minded, adaptable
and think “outside the box.” We are driven to always do our best
and we do not give up. We deliver and are accountable to promised
results. Important notice to employment businesses/agencies
Orchestra BioMed does not accept referrals from employment agencies
unless written authorization from the Orchestra BioMed Human
Resources department has been provided. In the absence of written
authorization, any actions undertaken by employment agencies should
be deemed to have been performed without our consent and therefore
Orchestra BioMed will not be liable for any fees arising from
employment agency referrals in respect to current or future
position vacancies at Orchestra BioMed.
Keywords: Orchestra BioMed, Hanford , Field Procedural Specialist, Science, Research & Development , Bakersfield, California