You will serves as the primary developer of firmware for a Class III medical device, overseeing the entire electrical development process from concept and design through validation, clinical trials, and commercialization.
Benefits:
- Full medical, dental, vision.
- 401k matching
- Company equity
Qualifications:
o 10+ years in embedded C++ development for safety-critical systems.
o Experience with Azure DevOps or similar environments.
o Familiarity with static analysis tools and automated unit testing (e.g., Parasoft C++ Test).
o Experience with Class II or III medical devices and regulated software development processes, particularly IEC 62304.
o Knowledge of Medical Device QMS, including Design Inputs, Risk Management, and Manufacturing Software Validation.
Technical Skills:
o Proficient in programming languages such as C, C++, C#, LabVIEW, and Python.
o Ability to read schematics and familiarity with electronic design/layout preferred.
o Ability to work collaboratively with engineers, technicians, and assemblers.
Education and Experience Requirements:
• Minimum BA/BS in a relevant discipline from an accredited university.
• 2-4 years in a senior or principal engineering role within a medical device company.
• Working knowledge of management quality system requirements for medical devices (ISO 13485:2016, ISO 14971:2019, (EU) 2017/745, FDA 21 CFR 820).
Duties and Responsibilities:
• Maintain implant software throughout its lifecycle.
• Specify software requirements based on system specifications, risk assessment mitigations, and security controls.
• Develop and maintain unit tests.
• Participate in design reviews, risk assessments, and security evaluations with various stakeholders.
• Develop and procure tools to support implant software development and testing.
• Document software architecture and module design descriptions.
• Review firmware and software design outputs.
• Access and work within GitHub for software development and bug tracking.
• Read, interpret, and apply software architecture, requirements, and design documents.
Manufacturing:
• Assist manufacturing with troubleshooting implant software during production and testing.
• Collaborate with the engineering team to develop solutions for manufacturing issues, including setting parameters and software validation.
• Develop, implement, and validate manufacturing software solutions.
• Specify, develop, and maintain manufacturing software scripts and spreadsheets.
• Document software and electronics issues identified during manufacturing and work with Systems Engineering to resolve them.
• Engage directly with assemblers, technicians, and engineers on the manufacturing floor as needed.
• Serve as the primary responder for software-related issues on the manufacturing line.
• Author, perform, and report on manufacturing software validation protocols.
