Bachelor's degree in Biomedical Engineering, Mechatronics, Computer Engineering, or related field.
5+ years of software testing experience in medical devices or regulated industries.
Strong knowledge of Verification and Validation (V&V) and Design Controls.
Familiarity with FDA requirements and relevant ISO standards (ISO 13485, ISO 14971, IEC 62304, EU MDR).
Experience with test equipment (oscilloscopes, multimeters) and diagnostic tools (SolidWorks).
Working knowledge of scripting tools (Python, LabVIEW, MATLAB).
Strong English communication skills, both written and spoken.
Responsibilities
Draft and execute formal test protocols.
Plan schedules for formal testing cycles.
Perform manual testing across multiple projects.
Review software requirements to ensure comprehensive testing.
Identify, document, and submit defects using defect-tracking applications.
Prepare weekly test metrics and present status reports.
Provide technical guidance to Software Test Engineers.
Benefits
Collaborative work environment with cross-functional teams.
Opportunity to work on innovative medical device projects.
Professional development and training opportunities.
Participation in Defect Review Board meetings for quality assurance.
Access to advanced testing equipment and tools.
Full Job Description
Job description
Amaris Consulting is looking for a Senior Software Test Engineer to perform manual software testing, verify product requirements, identify defects, and prepare test documentation in line with quality and regulatory requirements.
You'll support several projects, work closely with Software Quality Engineers, and provide guidance to Software Test Engineers. The role requires experience in medical devices or another regulated industry, with strong knowledge of verification and validation, design controls, software testing, and risk management. Your responsibilities
Draft and execute formal test protocols.
Plan schedules for formal testing cycles.
Perform manual testing across multiple projects.
Review software requirements and verify that they are fully tested.
Identify, document, and submit defects using the relevant defect-tracking application.
Follow defects through investigation, correction, retesting, and closure.
Prepare weekly test metrics and present regular status reports.
Participate in Defect Review Board meetings.
Work with Software Quality Engineers to follow up on features and defects.
Review and update digital work items used to track tasks, bugs, and requests throughout the project lifecycle.
Prepare test records and supporting documentation in line with the applicable QMS and regulatory requirements.
Support formal requirements drafting and review.
Provide technical guidance to Software Test Engineers.
Your profile
Bachelor's degree in Biomedical Engineering, Mechatronics, Computer Engineering, or a related field.
At least 5 years of software testing experience in the medical device sector or another regulated industry.
Experience performing manual testing across multiple projects.
Strong knowledge of:
Verification and Validation (V&V)
Design Controls
Software Development Life Cycle (SDLC)
Software testing
Hardware testing
Good understanding of FDA requirements and the following standards:
ISO 13485, Quality Management Systems
ISO 14971, Risk Management
IEC 62304, Medical Device Software Life Cycle Processes
EU MDR
Experience with test equipment such as oscilloscopes and multimeters.
Experience with diagnostic tools and CAD software, including SolidWorks.
Working knowledge of scripting and analysis tools such as Python, LabVIEW, or MATLAB.
Experience drafting and reviewing formal software requirements.
Good understanding of risk assessment and mitigation processes.
Strong written and spoken English.
Ability to lead testing activities and guide other Software Test Engineers.
