Join a dynamic Dutch scale-up specializing in innovative medical products for maternal and fetal health monitoring. As a mid-level Product Development Engineer, you'll play a crucial role in testing, validating, and documenting hardware/software products for regulatory clearance. Collaborate with a multidisciplinary team on cutting-edge technology, gaining hands-on experience in a high-impact field, all while enjoying a competitive salary and benefits package. Continue reading to see why we need your expertise.

Over het bedrijf

QTC Recruitment

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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.

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 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'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.

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