You will join a multi-disciplinary team of biomedical engineers, electrical engineers, industrial design engineers, signal processing and algorithm experts, software developers and clinicians and help bring medical devices to market. You will make a difference by bringing your expertise in hardware and embedded verification, scripting and automation and a great attention for detail. You will be responsible for the overall quality of the sensor nodes developed and ensure that Onera releases high quality devices. The position requires regular onsite presence based out of Eindhoven.
Key Responsibilities – What You’ll Do
You will have full responsibility over the verification of Onera’s devices.
Verification Planning:
- Develop comprehensive verification plans that align with project requirements and regulatory standards.
- Define verification strategies and methodologies to ensure complete coverage of system requirements.
Test Development:
- Design and develop test protocols, procedures, and test cases for system-level verification.
- Create and maintain automated test scripts and test environments.
Execution and Analysis:
- Execute verification tests according to established protocols and document results.
- Analyze test data to identify defects and areas for improvement.
- Work closely with development teams to troubleshoot and resolve issues uncovered during verification.
Documentation:
- Prepare and maintain detailed verification documentation, including test plans, protocols, reports, and traceability matrices.
- Ensure documentation complies with regulatory standards and quality management systems (ISO13485 and IEC 62304).
Risk Management:
- Participate in risk management activities, including hazard analysis and failure mode effects analysis (FMEA).
- Verify risk mitigations are effective through targeted testing.
Compliance and Quality:
- Ensure all verification activities adhere to regulatory and quality requirements.
- Support quality assurance in audits and inspections by providing verification documentation and evidence.
Cross-Functional Collaboration:
- Work with systems engineers, design engineers, and quality assurance to understand system requirements and design.
- Collaborate with regulatory affairs to ensure verification activities align with submission requirements.
You will work mainly from our office in Eindhoven.
Requirements
What you will bring:
- MSc or BSc degree in computer science, electronics, electrical, mechanical engineering, and a broad technical understanding and interest in medical devices
- Minimum of 3 year experience in a device testing role
- Experience in execution of (embedded) subsystem and system level tests both functional and non-functional (e.g. reliability, performance, etc.) including design, preparation and implementation of tests
- Experience with different test automation frameworks adequate for device system testing
- Experience with implementing test setups and (automated) test scripts – e.g. in C, python
- Have a pragmatic approach based on strict timelines and frequent refinement of remaining risks
- Ability to write and edit technical documents such as test protocols and technical reports
- A hands on, creative, flexible attitude with a result driven, can-do mentality
- Good familiarity with Git, Jira, CI/CD pipelines
More Information
- Experience Level Junior
- Total Years Experience 0-5
- Radio field Option 1
- Dropdown field Option 2
- Multiple Select field Option 3
- Checkbox field Option 2
