Field Clinical Engineer - ORCHESTRA BIOMED, INC.

About Orchestra BioMed

Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s vision is to accelerate medical innovation to patients through risk-reward-sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed is led by a highly accomplished, multidisciplinary management team and a board of directors with extensive experience in all phases of therapeutic device development. Orchestra’s business was formed in 2018 by assembling a pipeline of multiple late-stage clinical product candidates originally developed by its founding team. Its flagship product candidates are BackBeat CNT for the treatment of hypertension, the leading risk factor for death worldwide, and Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic for the development and global commercialization of BackBeat CNT for the treatment of hypertensive patients indicated for a pacemaker and strategic partnership with Terumo for the development and global commercialization of Virtue SAB for the treatment of coronary and peripheral artery disease.

Job Summary

Field Clinical Engineer 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 implantations. Currently, this will include the studies in our BackBeat and or Virtue programs but will 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 technical support during follow-ups and implantations or replacements where        applicable.
• Perform or supervise all device programming.
• Performs basic data analysis for patients in the site to ensure optimal parameter setting.
• 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 device programming and 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 a biomedical or other relevant scientific discipline with a master’s degree strongly preferred.
• 3+ years of related experience and/or training (Medical device); or equivalent combination of education and experience required.
• Experience and/or knowledge of the management of the clinical research processes for active implantable medical device trials with 2+ years of experience in cardiology trials.
• Good technical skills and excellent computer operating skills including Microsoft office
• Excellent presentation skills in a requirement.
• Basic physiological knowledge is desirable.
• 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.
• Leadership skills characterized by results and specific achievements.
• 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 shall 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.