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.