Job Description

ATTENTION C2C STAFFING VENDORS: Terms of our staffing agreement with our client expressly prohibit our use of candidates sourced by third-parties. Please do not waste your time or ours by inquiring about this job.

StarsHR has the following long-term contract opportunity available with our client in Greater Pittsburgh.

Embedded Software V&V Engineer

SUMMARY

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.

DUTIES & RESPONSIBILITIES

Verification and Validation of software for complex system interactions in medical devices, including

Embedded software

Platform software

Operating system 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

Writing reports

Responsible for verification of the software platform of the medical device, including:

Sub-system testing

Performance and reliability

Safety and interoperability

Review and analysis of product and software requirements

Defect characterization and reporting. Assist in triaging of the defects.

Compliance with standard operating procedures for medical device development, including compliance with ISO 13485 and IEC 62304

Critical analysis of technical situations; identifies problems, and work with the cross-functional team in resolving the problems.

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 Center of Excellence (CoE) in Software Assurance function.

REQUIREMENTS

Bachelors degree in engineering, preferably Computer, Electronics, or Biomedical

Minimum of 2 years of relevant work experience in software testing in medical device or in a regulated industry

Minimum of 1 years 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.

Understands 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.

This position is a long-term contract, potentially leading to perm. StarsHR can provide benefits while contracting through our company.

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