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.
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.
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
- 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
Interested in this vacancy? Send your motivation and CV to Eefke van Daal: email@example.com
For questions regarding the content of the vacancy, please contact Evert-Jan van Donkelaar, firstname.lastname@example.org, 06-82712185
Acquisition as a result of this vacancy is not appreciated.