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

· Bachelor’s 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.

Job Tags

Similar Jobs