System Engineer - Verification

The Job

Onera Health is looking for a System Engineer to complement our growing team. 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.

The Company

Onera Health is a leader in transforming sleep medicine and remote monitoring. Their breakthrough diagnostic solutions and services are poised to help millions of people struggling with sleep-related ailments, while also impacting other medical fields by monitoring a variety of chronic conditions, ultimately improving the health and quality of life for patients around the world. The company’s innovative solutions provide comprehensive sleep test data to physicians in a variety of clinical and non-clinical environments to optimize patient care and reduce healthcare costs.

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

Benefits

What We Offer

• Flexibility in work hours and hybrid location (in North Brabant region)
• Technical equipment to set up a home office
• An open and positive company culture, with a lot of team activities
• A competitive salary including a 13th month, participation in pension scheme, and Onera stock options
• A holiday package with 25 days and the option to buy additional days

Where We Are

Torenallee 42-54, 5617 BD (Strijp-S), Eindhoven, Netherlands -- #LI-Onsite