Founded in 2011 and currently employing 22 people, iSTAR Medical is a clinical-stage medical technology company that aims to provide leading patient care through the design, manufacturing and marketing of novel ophthalmic therapies.
iSTAR Medical develops innovative ophthalmic implants for patients with glaucoma. The ophthalmic implants are made from proprietary STAR® material, a technology from the University of Washington in Seattle (USA). For additional information about the company and the technology, please visit http://www.istarmed.com/
In order to support the development of the company, we are currently looking for a (m/f) :
(Senior) R&D Engineer
As a (Senior)-R&D Engineer, you lead and take care of designing, developing and testing the next generation of iStar implants and delivery systems, from the concept phase to human use. In collaboration with other team members, you identify innovative and reliable product designs. Reporting to the VP R&D, you play a key role in the R&D/innovation activities.
Your main responsibilities are:
- You conceptualize, design and develop the delivery systems, including design requirements, prototype developments, feasibility evaluations, pre-clinical and clinical assessments.
- You perform and document literature reviews to support customer requirements/design inputs identification, protocol design, pre-clinical studies.
- You support the development of new test methods, tooling and equipment procurement, and executing long term testing for the delivery tool.
- You manage R&D projects, within budget and agreed upon timelines
- You identify and manage suppliers to develop new products.
- You collaborate with colleagues and physicians in clinical developments in order to evaluate technology and to have a better understanding of ocular anatomy.
- You work with team members and external partners to deliver key technical objectives of the projects.
- You report results and work progress on a regular basis to the top management.
- You take ownership and responsibility for tasks assigned to you.
- Mechanical or Biomedical Engineering Master’s degree, PhD is a plus but not required.
- Minimum of 5 years industrial experience in design, development, scale-up and commercialization of medical products.
- Experience in medical device design (implant and/or instruments), usability engineering and manufacturing is required.
- Understanding and knowledge of Design Control, familiar with FDA, GMP, QSR and ISO13485 requirements.
- Strong innovation and communication skills together with hands-on and pragmatic mind-set.
- Very good organizational, analytical and problem-solving skills.
- Highly collaborative, self-motivated and team-oriented individual in a company setting.
- Excellent oral and written communication skills in English. Another language is a plus.
- You are prone to travel worldwide up to 15% of your work time to support product development and clinical investigation trials.
- A full-time permanent position within a high-potential medical device company with direct impact on the lives of patients.
- A professional, dynamic and stimulating work environment.
- A variety of interesting contacts with international exposure.
- An attractive compensation package in line with the position responsibilities and your experience.