Senior Field Engineer

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About this role:
Provide day-to-day field clinical study, technical/application and education support, site management, coordination and training for the Transcatheter Aortic Valve Replacement (TAVR) clinical programs. Promote clinical programs through education of current and new investigators by providing clinical strategy and case support to achieve company objectives.
 

Your responsibilities will include:

• Clinical Role
  • Assist in the site qualification, and initiation processes for TAVR trials in the US. Support Clinical department, Clinical Research Associates (CRA – Monitors and technical support) in ensuring and documenting clinical site and investigator readiness for participation in an investigation trial
  • Key contact with the physicians and the research team during the patient screening and enrollment for TAVR clinical investigation, providing the support needed to collect all required screening materials for review by the assigned review committee and/or the sponsor
  • Assist the Clinical department and the hospital research team during the conduct of the study, as well as after the TAVR procedure, in all study-required data collection, including but not limited to adverse and serious adverse events reporting, source data collection, CT and echocardiographic images, etc.
  • Device Management: Monitor inventory levels, initiate logistics, i.e. shipments and movement tracking of investigational products according to regulatory and company guidelines. Monitor the levels and expiration dates of investigational product in the field. Coordinate communication between internal and external customers to facilitate return of product according to departmental SOP
  • Ensure clinical trials are compliant to regulatory and company guidelines
  • Supports company goals and objectives, policies and procedures, Good Clinical Practices and regulatory agencies regulations
• Education/Training Role
  • May assist in the development of the TAVR training plans/materials. This includes but is not limited to: hands-on training such as simulated procedures and SIM models, as well as training materials development and preparation. Presentation of didactic sessions, study cases and other training-related presentations at investigator and research coordinator meetings, and other training events
  • Educate and train physicians, hospital personnel and hospital staff on technical matters relating to the company products by conducting and/or coordinating one-on-one training sessions, in-service education programs, and seminars and/or outside symposiums. Provide training and resources for hospital staff to enable them to conduct training for their personnel ("train the trainer")
• Technical/Engineering Role
  • Assist in the clinical study procedure (sterile field), playing a key role in device preparation, as well as providing technical support and device and system troubleshooting as needed. Key role in maintaining compliance for peri-procedural data capture (images, steps of device delivery and performance, operators’ feedback, etc.) during the study procedure, enabling close monitoring of the device performance and procedural enhancement through constant communication with the field engineers
  • Responsible of the development of the internal case summary reports template as well as their completion
  • Work closely with the in-house engineers, participating in regular on-site training on the design implementation of the device, as well as any changes related to the design. Communicate design changes to the field as appropriate
     

Required qualifications:

• Bachelor Degree and higher in Engineering, Sciences, Nursing or equivalent
• 8 + years Clinical Research experience including coordinating multi-center trials and/or significant experience in the structural heart field with established technical expertise and knowledge
• Experience in presenting, writing and teaching clinical and medical information
• Experience with group presentations and hands-on experience with interventional/surgical cardiac procedures
• Ability to travel approximately 75%

Preferred qualifications:

• Excellent written and verbal communication skills, very strong interpersonal skills including proficiency in medical terminology
• Clinical Research experience in Medical Device
• Experience coordinating multi-center Cardiology trials
• Knowledge of Good Clinical Practices and ICH Guidelines and compliance for clinical trials
• Personal computer skills, including proficiency in word processing, spreadsheet and computer database skills
   

Requisition ID: 559650

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.