Biomedical Product Engineer

☞ Biocartis

View: 115

Update day: 07-11-2025

Location: Mechelen Antwerp

Category: High Technology

Industry: Biotechnology Research

Position: Associate

Job type: Full-time

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Job content

The Biomedical Product Engineer will support development, optimization and maintenance of disposable products or sub-systems and ensure their proper functional integration in the Idylla system. The Biomedical Product Engineer will support process development/engineering activities related to the integration of novel assays/tests onto the platform and provide technical knowledge and boundaries to these products in development. The Biomedical Product Engineer will lead problem-solving activities in multidisciplinary and cross-functional teams.

Accountabilities

Support development, optimization and maintenance of the systems:

  • Performs feasibility studies for new products or features;
  • Propose design and process improvements;
  • Plan, execute, analyze and document experiments;
  • Ensures compatibility between Idylla Platform and Idylla test menu.

Lead problem solving activities:

  • Analyze problem following appropriate scientific methodology (DOE, DMAIC, RATIO etc.);
  • Plan, execute, verify, validate implementation of solutions;
  • Document progress and results and communicate to internal stakeholders;

Ensure compliance with international standards and regulations (IVD).

Profile requirements

  • Master in Engineering or equivalent by experience;
  • Preferably 2+ years’ experience in a relevant industry;
  • Industry experience related to medical devices (preferably IVD) is a pre;
  • Knowledge of system engineering principles, such as design and development process, verification/validation, requirements management and risk management;
  • Knowledge of quality and compliance standards for development of medical devices / IVD Systems (ISO13485, ISO14971, FDA 21 CFR part 820);
  • Understanding of PCR, fluorescence detection, sample preparation and DNA enrichment technologies is an advantage;
  • Experience with medical devices/molecular diagnostics platforms is an advantage;
  • Skills:
  • Hands on
  • Analytical thinking
  • Accuracy
  • Decision making
  • Communication
  • Data analysis and statistics
  • PC skills:
  • MS Office
  • Data analysis/statistical tools (e.g. R, Python, SpSS, Minitab)
  • Languages:
  • Advanced knowledge of English, both orally and in writing, Dutch would be an asset.

Our offering

We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment.

You will have freedom to shape your work and shape your job. Your input is highly appreciated.

Of course we offer you a fitting compensation package which includes a Flexible Income Plan.

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Deadline: 22-12-2025

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