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Systems Test Engineer
Your role:
Create Verification and Validation plan.
Testing and debug of critical sub-assemblies.
Conduct early dry run testing of system verification test procedures to ensure their high accuracy as well as provide timely information on product performance to the project team.
Perform system-level formal verification prior to production release to identify problems.
Perform V&V activities for FDA and EUMDR remediation projects.
Design test protocols and develop test methods
Reporting and documenting the test results in test reports and where appropriate entering defects into the defect tracking system.
Enables and/or performs functional testing through the development of robust and reusable tests.
Work with design teams to isolate design errata, perform failure analysis, and verify design fixes.
Support and work collaboratively with external teams to verify system performance.
Supporting the test estimation and planning activities.
Ensuring that all verification activities are conducted in accordance with Quality System requirements.
Following improvements in the profession of test engineering.
Mentor team members.
Ability to implement process automation / innovation.
Ability to learn new PLM/ALM tools and become productive.
You're the right fit if:
Bachelor’s or Master’s degree in Mechanical / Electronics / Electrical / Biomedical Engineering with a broad technical understanding and interest.
Minimum 6 to 9 years of experience on system verification and validation of medical devices.
Experience on V&V of ventilator will be preferred.
Hands on experience of test method validation.
Hands on experience of remediation projects for FDA or EUMDR.
Understand and Comply with Philips QMS.
You are process oriented with basic knowledge of FDA and/or ISO/IEC regulations.
Technical documentation authoring and editing skills.
Good written and verbal communication skills.
Ability to work across functional groups.
Familiarity with quality procedures and documentation.
Proficiency with MS Office MS excel or equivalent.
Good communication of both written and spoken English.
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