Senior Software Engineer

JOB SUMMARY

The Sr. Software Engineer will be responsible for software design and development activities for medical devices including maintenance and documentation. The Senior Software Engineer performs across the entire software development cycle to create new system capability and improve the performance and reliability of existing software systems. This role will contribute to the full life cycle of multiple cross functional projects, including product definition, identifying functional requirements, design implementation, code reviews, release and transfer of design according to medical device development processes.

• Works as a Software Engineer within the full life cycle for medical device software on 1-2 projects concurrently, meeting medical device regulatory requirements, such as IEC
  62304, ISO
  13485 and CFR
  820.30
• Designs and Develops software, integrates on product hardware, and performs informal or formal testing as appropriate
• Interfaces with and maintains configuration and versioning for build, test, and source control tools used in assigned projects
• Creates and Executes protocols for Software Verification & Validation
• Creates and updates Software specific design documentation, including analysis reports supporting software Documentation Level and Safety Classification
• Participates in the system and software risk management processes
• Participates in design and code reviews
• Supports legacy software through debugging and troubleshooting
• Provides an effective bridge between software and hardware personnel and lead/coordinate timely completion of the technical deliverables
• Supports the design transfer of software

• Bachelor's degree in software engineering, computer science, computer information systems or equivalent
• 4 - 8 years of industry experience as a developer of medical device product software or similar work in another regulated industry
• Modern object-oriented programming experience such as C++, C#, Python or Java
• Experience with a variety of operating systems (e.g. Windows, Linux, Real Time)
• Familiarity with FDA QSR, and ISO 13485, IEC 62304, FDA design controls
• Cybersecurity in medical devices and implementation of security controls
• Self-directed and able to problem solve independently and as part of a team

EOE Statement:
Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

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