Manager, Field Clinical Engineer

2 weeks ago

San Mateo, United States Presidio Medical, Inc. Full time
Job Summary:

Presidio Medical is looking for a knowledgeable and passionate individual to be the Manager of Field Clinical Engineering team. This individual will report to the VP of Clinical Affairs. This individual will manage the FCE team as well function as an FCE. This individual serves as a liaison between Clinical Research Sites, study participants and the company regarding technical issues. Responsibilities encompass clinical trial execution tasks, troubleshooting, and identification and communication of potential future product features.

Additionally, the individual will convey observations regarding the device or therapy to the research and development engineering teams and assist with the product development process.

The ideal candidate should be well versed in clinical research for medical devices in both the

pre-market and post-market spaces, be naturally curious and a creative problem solver. He or she should be able to work with a diverse group and able to execute an evidenced plan with both internal and external stakeholders.

Essential Duties and Responsibilities:

  • Management of the FCE team
  • Conduct Field Research.
  • Manage the implantation, programming, troubleshooting, and in-person data collection either personally or deploying personnel resources during the conduct of clinical research.
  • Contribute to the design of clinical studies as needed.
  • Contribute to planning and logistics of a clinical trial during the start-up phase.
  • Serve as a liaison between Presidio Medical and the clinical research staff/sites.
  • Provide and/or supervise education and training to Investigators and Research staff with investigational devices and associated surgical implant supplies.
  • Interface with the R&D department regularly on a technical level to convey clinical requirements, technical data, and general observations.
  • Assist with the management of clinical supply including inventory, shipping, and receiving.
  • Assist Clinical Operations with the ongoing review of reported adverse events throughout the study.
  • Assist Clinical Operations with accurate study status and Investigational Product accountability.
  • Work cross-functionally with representatives from other key functional groups including Research and Development, Regulatory Affairs, Quality, Legal and other groups as needed.
  • Assist and collaborate with process improvement exercises.
  • Comply with Presidio Medical's quality system requirements as well as any applicable regulatory requirements.
  • Comply with all health and safety regulations, policies, and work practices.
  • Other duties as assigned.
Qualification Requirements:

Experience:
  • 2+ years of management experience
  • 3-5+ years of neuromodulation experience.
Knowledge/skills/Abilities:

Required
  • Field management experience
  • Must have SCS experience:
  • Working directly with SCS subjects (education, therapy management, troubleshooting)
  • Working directly physicians for operating room case support
  • Strong knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials.
  • Strong working knowledge of technical aspects of programming SCS subjects.
  • Good communication skills and a team player who can use positive methods to motivate his/her team and collaborate and build good working relationships with other internal departments.
  • Good organizational skills, punctuality, and ability to meet tight deadlines in an environment of competing priorities. Ability to routinely work on multiple tasks with multiple people while effectively prioritizing.
  • Excellent interpersonal skills including problem recognition and solution definition with strong attention to detail, accuracy, and organization.
  • Flexibility to travel as needed to support the development and conduct of clinical trials.
  • Computer skills including experience with Microsoft Office
Nice-to-have
  • At least 1 year of Clinical Research experience in medical device clinical trials.
  • Previous experience with multiple potential competitor devices.
Education:
  • Bachelor's degree in engineering field or medical specialty (ex. RN, PT) or 3+ years of requisite experience.
Physical Demands:
  • Varied sitting, standing, and walking.
  • Ability to lift and carry 50lbs. or less.

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