Latest career opportunities with SurgVision

The Company:

We are a high-tech startup company based in 't Harde, The Netherlands, active in development of innovative optical imaging devices and reagents in the medical and pharmaceutical industry. We are looking for an engineer to help us on our journey from product development, to (small series) production, service and eventually industrialization.

Your role:

  • Work hands-on in the development, manufacturing, testing and field service of imaging devices.
  • Coordinate suppliers and external engineering partners for device development and manufacturing.
  • Provide technical support on-site at hospitals during clinical trials (world-wide).
  • Provide on-site customer service and training.
  • Generate documentation to support regulatory processes and coordinate device certification and testing processes.

Education and Experience:

  • Preferred Bachelor's degree in Technical Medicine, Electrical Engineering, Mechanical Engineering or a comparable field of study.
  • 3 years work experience, ideally at a medical device manufacturer.
  • Experience with cameras or other optical systems is a plus.

Ideally you would display multiple of the following skills:

  • Generation of technical documentation required for medical devices.
  • Proficiency in hands-on mechanical work for manufacturing and service of devices.
  • General knowledge of electronics and microcontrollers.
  • Basic knowledge of optics, particularly cameras and illumination.

In addition, good English and Dutch oral and written communication skills are required.

We Offer:

  • Being part of a small team in an exciting industry
  • Competitive re-numeration
  • Personal development along with company growth

Clinical Development Manager ref: SVC001

Location:

Essential Job Functions:

‘t Harde, The Netherlands

  • Proactively drive and develop the set up of upcoming clinical studies.
    Generate all necessary documentation to obtain approval to start clinical trials in the EU and USA.
  • Interact with official authorities, e.g. FDA, BfArM, NHS etc. to support effective completion of registration
  • Develop a process for improvement of Clinical Study standard operating procedures (SOPs) and templates.
  • Develop internal processes for complaint handling with regard to clinical trials.

A high-tech innovative start-up company active in equipment development of devices and tracers in the medical and pharmaceutical industry. Activities range from concept creation, product and process development, to prototyping and (small series) production and eventually industrialization.

Experience:

  • Minimum of 3 years experience through a clinical research organization or Medical Device / Pharmaceutical industry.
  • Experience with the design of clinical trials and clinical end-points.
    A demonstrated working knowledge of GCP, ICH guidelines, FDA regulations as well as EU regulations.
  • Experience with execution of clinical trials.
  • Experience with EDC and Data Management.
  • Preferably medical education, or education in medical related science (Master)
  • Strong organizational abilities.
  • Proficient computer skills across multiple applications with experience in and an aptitude for clinical trial software.
  • Excellent English oral and written communication skills