StarsHR, Inc. · 2 days ago
Embedded Software V&V Engineer
Pittsburgh, PA
Contract
Onsite
Entry, Mid Level
2+ years expStarsHR, Inc. has a long-term contract opportunity available for an Embedded Software V&V Engineer responsible for performing software verification and validation of medical devices. The role focuses on ensuring high-quality products that meet customer expectations and comply with FDA design controls.
EmploymentRecruitingStaffing Agency
Hiring Manager
John Clark
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
Qualification
Required
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.)
Preferred
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
Benefits
StarsHR can provide benefits while contracting through our company.
Company
StarsHR, Inc.
StarsHR’s mission is to help our clients acquire the highest quality technology professionals for their needs promptly and flexibly.
11-50 employees
H1B Sponsorship
StarsHR, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (4)
2021 (2)
2020 (2)
Funding
Current Stage
Early StageCompany data provided by crunchbase