Senior Design Assurance Engineer (m/w/d)

Position: Senior Design Assurance Engineer

Hiring Manager(s): CTO

Location: Heidelberg, Germany

Company Overview:

Precisis is a well-funded startup, developing neuromodulation technologies focused on functional brain diseases, specifically epilepsy and neuropathic pain. Minimal invasiveness and precise targeting of stimulation therapy pose distinct advantages over currently available technologies in the market and are the foundation of Precisis projects. Our first product, the EASEE® System, is currently under clinical evaluation and will be launched in 2021.
The Precisis team of 15 consists of experienced and entrepreneurial-minded individuals with the common goal of bringing to the market next generation neuromodulation solutions.

Position Description:

Precisis is looking for a dynamic individual to:

  • Take over responsibility for further development of the technical file(s)
  • Manage verification planning and execution to achieve CE/FDA regulatory approvals, including management of external test laboratories
  • Identify technical needs and solutions to leverage scale up and international market access for Precisis products
  • Support development, verification and regulatory approvals of a growing product portfolio in international markets

Experience / Capabilities:

  • Academic degree in a technical field of study, ideally with a mechanical focus
  • At least 3yrs of experience in R&D or QA role in the medical device industry
  • Proficient in state-of-the-art processes in medical device development (e.g. V-model, requirement engineering, risk management, test method validation)
  • Profound experience in verification testing of class III medical devices, ideally AIMD (active implantable medical devices) and/or implantable leads
  • Preferably experience in interactions with the FDA
  • Process-orientated, solution focused personality with can do attitude
  • Business fluent English

Precisis AG (www.precisis.com) is associated with exceptional achievements with medical devices in the field of brain therapy. Our latest development, the fully implantable EASEE neurostimulation system, will provide a modern and low-risk method for the suppression of epileptic seizures in drug resistant patients. EASEE is a minimally invasive brain stimulation method, pioneering the future treatment of functional brain diseases. Join your ideas, expertise and commitment to our international team to offer innovative medical device solutions to our customers, physicians and patients.

If you have any questions, please contact us at +49 6221 6559300.
Please send your collected application documents in pdf-form to info@precisis.de.