Embedded QA Engineer

Location: Europe (Remote/Hybrid)
Travel: Required (client onboarding)
Employment type: full time

About the Role

Devico is seeking an experienced QA Engineer with a strong background in embedded software black-box testing to support a long-term engagement with an international medical device manufacturer. The project involves the full test lifecycle for embedded software modules within mechatronic medical devices and requires strict adherence to IEC 62304-compliant processes and client toolchain standards.

The successful candidate will work closely with the client's engineering and regulatory teams and must be prepared to travel to the client's European site for initial onboarding and training.

Key Responsibilities

• Derive test cases from software requirements specifications and implemented features.
• Document test specifications in accordance with IEC 62304 and client documentation standards.
• Develop and maintain manual and automated test scripts for embedded software modules.
• Execute tests on PC-based test environments connected to the device under test (DUT).
• Work with hardware test setups including boards, nodes, emulators, and measurement equipment such as logic analyzers.
• Analyze test results and logs; prepare structured test reports.
• Document identified defects in the designated bug tracking system (Polarion ALM).
• Maintain full traceability from requirements through test cases to results and defect records.

• Collaborate with development and regulatory teams to support audit-ready documentation.

   

Requirements

Location and Availability

• Based in Europe, or legally authorized to work in Europe with unrestricted travel capability.
• Ability to travel to the client site (Germany) for onboarding, training, and periodic review sessions.

• Available for engagement within the client's working hours (CET/CEST time zone).

   

Technical Experience

• Minimum 3 years of hands-on experience in embedded software testing (black-box, grey-box).
• Proven experience with PC-based test environments connected to physical hardware devices.
• Practical knowledge of hardware interfaces and test equipment: logic analyzers, emulators, boards, nodes, CAN, UART, SPI, or similar protocols.
• Experience writing test cases and test specifications from formal software requirements documents.
• Experience with test automation frameworks applicable to embedded or systems-level testing.
• Proficiency with Git for version control of test artifacts and scripts.
• Experience with Polarion ALM or comparable requirements/test management tools (e.g., DOORS, Jama, Xray).

Domain Experience

• Experience in medical devices, industrial automation, automotive, aerospace, or other safety-critical or regulated industries.
• Familiarity with IEC 62304 (Software lifecycle for medical devices) or comparable standards such as IEC 61508 or DO-178C.
• Understanding of regulatory documentation requirements and audit readiness (CE, FDA, or equivalent).

Nice to Have

• Direct project experience working under IEC 62304 with a Notified Body or internal audit process.
• Knowledge of ISO 13485 (Quality Management Systems for medical devices).
• Experience with HIL (Hardware-in-the-Loop) or SIL (Software-in-the-Loop) test environments.
• Familiarity with mechatronic systems, prosthetics, orthotics, or rehabilitation devices.

• Experience working in a distributed team across multiple European time zones.

   

Certifications (Welcomed)

• ISTQB Certified Tester - Advanced Level (Test Analyst or Technical Test Analyst).
• ISTQB Certified Tester - Specialist: Embedded Software Testing.
• Training or certification in IEC 62304, ISO 13485, or related medical device standards.
• Any relevant safety-critical systems certification (TUV, functional safety, etc.).

We Offer:

• Remote work and flexible working hours.
• Legal support.
• Paid sick leaves.
• Paid vacations and weekends on public holidays.
• Free English classes.