Embedded Tester

StarsHR, Inc.; Pittsburgh (Allegheny County); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading healthcare technology firm in Pittsburgh seeks a Software Verification and Validation Engineer to ensure high-quality software for medical devices. The role involves developing verification protocols, analyzing requirements, and collaborating across teams. Candidates should have a degree in engineering and experience in medical device software testing. Knowledge of C/C++ and Python is preferred. This position offers the opportunity to contribute to continuous improvement initiatives in software assurance.

Qualifications

• Minimum of 2 years of relevant work experience in software testing in medical devices.
• Minimum of 1 year of relevant work experience in software test automation.
• Familiarity with Software Development Lifecycle processes.

Responsibilities

• Perform software verification and validation for medical devices.
• Develop and execute software verification protocols.
• Review and analyze product and software requirements.

Skills

Software testing

Test automation

Technical writing

C/C++ programming

Python programming

Education

Bachelor’s degree in engineering

Tools

Test frameworks

Embedded RTOS

Job description

This position will be responsible to perform software verification and validation of medical devices to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls.

Responsibilities

• Verification and Validation of software for complex system interactions in medical devices, including embedded software.
• Development and execution of manual and/or automated software verification protocols, including design and development of test scenarios.
• Authoring and review of test cases and protocols; performing execution of test cases.
• Responsible for verification of the software platform of the medical device, including performance, reliability, safety and interoperability.
• Review and analysis of product and software requirements; defect characterization and reporting; assist in triaging of defects.
• Compliance with standard operating procedures for medical device development, including ISO 13485 and IEC 62304.
• Critical analysis of technical situations; identify problems and work with cross-functional teams to resolve them.
• Collaborating within cross-functional teams across multiple geographies to convey problems, opportunities, solutions, and results in medical device R&D activities.
• Engaging in continuous improvement initiatives to establish a Center of Excellence (CoE) in Software Assurance function.

Requirements

• Bachelor’s degree in engineering, preferably Computer, Electronics, or Biomedical.
• Minimum of 2 years of relevant work experience in software testing in medical devices or in a regulated industry (e.g., transportation, defense).
• Minimum of 1 year of relevant work experience in software test automation.
• Familiarity with Software Development Lifecycle processes, including Waterfall and Agile methodologies.
• Familiarity with C/C++, Python languages and test frameworks.
• Understanding of impacts of hardware constraints on software environment.
• Familiarity with ST microprocessor, FPGA, BLDC, peripheral device communication and embedded RTOS.
• Technical writing ability – clear and concise writing easily understood by multiple audiences (testers, auditors, peers, etc.).

Preferences

• Experience designing and developing medical device software in a regulated environment while adhering to FDA Design Controls and software process guidelines for medical devices including ISO 13485 and IEC 62304.