Compliance Engineer

Eindhoven / Enschede Bachelor/Master  Fixed contract   32-40 hrs/wk

Keywords: Accurate, Electronics, Mechatronics, Law & Regulations, Verification – Validation, Product & Process; Product safety and CE release.

Working at Holland Innovative means carrying out assignments at the customer with passionate professionals or giving training courses in various fields.

We are looking for a Compliance Engineer with a focus on product development for Medical, Automotive or High Tech applications.  The position is a challenging mix of expanding this competence within HI as well as deepening one’s own knowledge through close collaboration with some experts in this field.

 

Job description

As a Compliance Engineer you help organizations with product compliance. You contribute to identifying product-specific  laws and  regulations that the device must comply with. You ensure that a product is safe and future-proof because, for example, it does not interfere with other equipment. You also contribute  to setting up and maintaining the technical documentation, for example when drawing up test requirements in accordance with the applicable standards or by supporting validation activities on products or processes. You are in close contact with test houses and notified bodies and you work together with the Project Leaders & QA-RA specialists from the HI team or at the customer.

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Tasks and responsibilities

  • Product development guarantees the applicable product specific standards such as the IEC 60601-1 series
    • checking designs
    • drawing up requirements
    • training & coaching development teams
  • Setting up / executing a Risk Management System / Analysis according to, for example, ISO 14971
  • Drawing up / developing / executing test plans
  • Drafting / developing / executing process or product validation

 

Function requirements

  • Completed bachelor or master in a technical  direction such as  Electrical Engineering  or  Physics
  • Experience in the role of Compliance Engineer or Design Engineer is a plus, but not necessary. Within HI you work together with an expert in the field of compliance.
  • Knowledge of IEC 60601-1 / IEC 60601-1-2 / IEC 61010-1/ ISO 14971/ISO TS16949 is a plus.
  • Fluent in English, Dutch is a plus
  • Result- and customer-oriented I good social skills I accurately | passion I curious I eager to learn

What do we offer?

  • A flat organization with an open culture and extensive knowledge sharing between colleagues
  • Extensive training opportunities both at our own Academy and outside the organization
  • Possible to work in varied environments, both inside and outside the Netherlands
  • Option to work on your own innovation projects
  • Good conditions including 28 vacation days plus option to buy vacation days

 

More information

Interested in this  vacancy? Send your motivation and CV to Eefke van Daal: hrm@holland-innovative.nl

For questions regarding the content of the vacancy, please contact Evert-Jan van  Donkelaar,  evert-jan.van.donkelaar@holland-innovative.nl, 06-82712185

Acquisition as a result of this vacancy is not appreciated.