icotec designs, develops and manufactures innovative, high strength surgical implants from carbon-fiber-
reinforced PEEK polymer for the treatment of patients in the area of spinal and trauma surgery. icotec
has become a global leader in the area of carbon-fiber-reinforced implants based on its Composite Flow
Molding technology.

icotec is recruiting for a New Product Development Engineer to further strengthen its Development Team.
The position will be based at icotec’s headquarter in Altstätten (SG), Switzerland.

New Product Development Engineer

Position Functions

• Design and development of new surgical implants based on icotec’s BlackArmor® Carbon/PEEK
  material and technology, including the required surgical instruments for the system


• Coordinate with surgeons, engineering, manufacturing, quality, regulatory affairs, sales
  consultants and other functional departments to define and develop product requirements and
  concepts


• Generate product models, concept layouts and prints using CAD software


• Verification/validation testing including authorship of protocols and reports


• Create and maintain Design Control related documentation such as risk and usability
  assessments, user needs, design inputs, etc. Comply with requirements of design controls and
  other regulatory bodies


• Engineering support through production scale up

Qualifications

• Engineering Degree (MSc, BSc) in biomedical engineering or related discipline


• Minimum of 2 years of experience in product development of medical devices


• A work style of hands-on involvement with all phases of a development project


• Experience in authoring technical reports and supporting regulatory documentation; familiar with
  regulatory submission processes (e.g. EU, USA)


• Experience working in medical device regulations, including GMP, QSR and ISO quality system
  requirements


• Knowledgeable in the use of a CAD system


• Proficiency utilizing the MS Office Suite


• Must be fluent in German and English

Please send your CV to Ms. Anja van Hassel Tel. +41 71 757 00 59, anja.vanhassel@icotec.ch

icotec ag, Industriestrasse 12, 9450 Altstätten, Schweiz, Telefon: +41 71 757 00 00, www.icotec-medical.com