Biomedical Product Engineer

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, orally and in writing of English

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.

We work hybrid which means 3 days in the office and 2 days work from home.