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System Architect
Overview:
QTC are partnered with a Dutch scale up specialiSing in the development of medical products for maternal and fetal health monitoring. They currently have 2 fully completed CE-certified products in the EU market and are in the process of expanding to the US with the FDA. Due to continued growth, we are searching for a mid-level Product Development Engineer to support on testing, validating, and documenting hardware/software products for regulatory clearance and deployment.
Details
Medical Devices
Engineering
Veldhoven - Netherlands
40 hours per week
Get to know
Your consultant
About your role
This is how you will make the difference
Responsibilities:
Design, develop, and test all medical device product components to accurately monitor performance
Lead design verification and validation to applicable standards, including IEC 60601
Communicate with development partners to ensure all requirements for control tests and procedures are established during design, development, and manufacturing
Support in identifying and optimising technical deficiencies in device products
Work closely with quality to ensure all technical documentation is accurately prepared for regulatory approval, including FDA and CE-marking
what's needed
What you bring
Profile:
- Minimum BSc in technical or medical field – e.g. medical/biomedical engineering
- 3-7 years experience working within a product development or R&D function in a highly regulated industry, preferably related to ISO-13485 and MDR
- Strong background in Verification and Validation activities, including electronic understanding related to IEC standards
- Affinity to quality, with knowledge of preparing technical files for FDA a plus
- Strong communicator in English, Dutch is a plus
What we offer
What's in it for you
Offer:
- Work on cutting-edge medical technology that makes a real difference in healthcare.
- Collaborate with a dynamic and multidisciplinary team.
- Opportunity to gain hands-on experience in a high-impact field.
- Competitive salary and benefits package.
Send your application