Staff Software/Firmware Engineer - Oxenham Group LLC

Staff Software/Firmware Engineer Class III Medical Devices

Our client is seeking a firmware designer for a Class III medical device to drive all aspects of electrical development, from concept and design through verification & validation (V&V), clinical trials, and commercialization.

Key Responsibilities:

Design & Development:

• Lead the lifecycle maintenance of implant software.
• Define software requirements based on system specs, risk mitigations, and security controls.
• Develop and maintain unit tests to ensure software reliability.
• Participate in design reviews, risk assessments, and security evaluations with cross-functional teams.
• Create tools to aid software development and testing.
• Document software architecture and module designs.
• Review firmware and software outputs for accuracy and quality.
• Work within GitHub for software development and bug tracking.
• Interpret and apply Software Architecture, Requirements, and Design documentation.

Manufacturing Support:

• Troubleshoot implant software during manufacturing and testing phases.
• Collaborate with the engineering team to address manufacturing challenges related to software, including parameter setting, calibration, and software verification.
• Develop and validate software solutions for manufacturing needs, including scripts and spreadsheets.
• Work closely with assemblers, technicians, and quality engineers to address on-floor issues.
• Serve as the primary contact for software-related manufacturing line issues.
• Author and execute validation protocols and reports for manufacturing software.

Qualifications:

• 7+ years of embedded C development experience in safety-critical systems.
• Familiarity with Azure DevOps or similar environments preferred.
• Experience with static analysis tools and automated unit test environments (e.g., Parasoft C++ Test).
• Hands-on experience in Class II/III medical device electronics.
• Deep understanding of regulated software development (IEC 62304).
• Experience working within Medical Device Quality Management Systems (QMS).
• Strong knowledge of risk management, design controls, V&V, manufacturing software validation, and compliance processes (NCMR, CAPA, etc.).
• Proficient in C, C++, C#, LabView, or Python.
• Ability to read schematics; electronic design and layout experience a plus.

Education & Experience:

• Bachelor's degree in a related field (BA/BS) required.
• Minimum of 7 years of experience in embedded systems, with 2-4 years in a senior or principal role within a medical device company.
• Familiarity with management quality system requirements for medical devices (ISO 13485:2016, ISO 14971:2019, (EU) 2017/745, FDA 21 CFR 820).

This person will be an onsite member of the manufacturing team located in Westfield, Indiana.