Signal Processing Engineer - Medical Devices

Onera Health

Eindhoven, Netherlands

Onera Health is on the lookout for a seasoned engineer who is passionate about making a meaningful impact in the medical device industry. In this role, you'll be at the forefront of exciting product development projects that aim to transform sleep medicine and enhance patient care across the globe.

Responsibilities

The key purpose of this position is to contribute to the design and development of Onera products (SW and HW/electronics), with a focus on signal processing, and to ensure that they meet all functional, technical and regulatory requirements. Your tasks and responsibilities will include:

Design and Development:
- Develop signal processing algorithms for medical devices;
- Create detailed component specifications.
Testing and Validation:
- Develop and execute test plans to validate the performance and safety of developed components;
- Perform troubleshooting and debugging, including board bring-up, design of test tooling and adaptation of existing platforms to new specifications;
- Document test results and prepare technical reports.
Regulatory Compliance:
- Ensure developed components meet relevant medical device regulations and standards (e.g., FDA, ISO 13485, IEC 60601);
- Participate in risk management activities and ensure compliance with standards.
Collaboration and Documentation:
- Work closely with cross-functional teams;
- Generate and maintain technical documentation, including design specifications, validation protocols and user manuals.

Requirements

Bsc or Msc (preferred) degree in a relevant technical field (i.e. Computer Science, (Biomedical) Engineering, Electronics);
More than 5 years of product development experience, including integration and validation, preferably related to medical devices;
Broad SW development skills:
- C#/C/C++ proficiency. Knowledge of Python for testing and automation;
- Proficiency in Matlab or Python;
- Knowledge of Machine Learning techniques is a plus.
High level of expertise with regards to (digital) signal processing and related electronics and software;
Excellent problem solving, interpersonal and communication skills;
Strong focus on quality assurance and compliance;
Strong attention to detail and ability to meet deadlines;
Ability to create and maintain technical documentation.