Senior Software Engineer Opening In Medical devices at Westface Medical
Senior Software Engineer – Medical devices – C/C++
If you are a Senior Software Engineer with medical device and an embedded C/C++ background, please read on! Based in Truckee, with R&D operations in Redwood City CA, we are a Medical Device startup developing opto-electro-mechanical devices for image-guided surgery. We are looking for a great software engineer to support medical device development from early R&D concepts through prototype and full development including pre-clinical testing, clinical evaluations, and regulatory approval.
Provides software design, development and support leadership in a small cross-functional product development team developing a state-of-the-art image-guided surgical system. Works with company principals, other engineering disciplines and KOL physicians to design medical devices, resolve technical problems, ensure compliance to industry and regulatory standards. Devises new approaches to problems encountered. Works independently with minimal supervision but obtains guidance on unusual or complex problems and supervisory approval on proposed plans for projects. Maintains and supports a collegial work environment of continuous improvement in support of company Quality Policy, Quality Management System and compliance to the appropriate regulations. Designs and develops products and enhancements which are consistent with a zero-defect level and low product cost. Generate test protocols and conduct testing.
What You Will Be Doing – Using your experience and knowledge of systems design, software engineering, and medical devices to participate in the design and development of the software for the company's products and intellectual property. Leads the development of the SRS and SDD documents for the projects. Participates in FMEA, risk assessment, requirements definition, software architecture and detailed design, implementation, and software verification and validation. Defines tasks associated with all phases of software development and provides accurate estimates of required effort and project completion dates. Develops and executes unit tests to verify functionality of software modules. Provides software engineering expertise for the continuous improvement of product and process. Accurately and thoroughly documents work in support of ANSI/AAMI/IEC 62304:2006, ISO13485, FDA GMP and the requirements of all other relevant standards and all necessary documentation for planned regulatory filings.
Specific Duties and Responsibilities:
1) Development of the UI and customer-facing software in support of an image-guided surgical tool intended for use in time-critical procedures placing a premium on accuracy and image fidelity.
2) Back-end (data acquisition and analysis) and front-end (UI) code integration and optimization for display speed, minimizing latency while maintaining image quality and clinical relevance.
3) Work with optical and mechanical engineering to ensure seamless integration of the engineering disciplines into the final product.
4) Build and maintain company software development framework and infrastructure compliant to medical device standards and industry best practices.
Education/ Experience: Bachelor’s Degree in Software Development, Computer Science, or equivalent degree 4+ years of technical experience in Software Development in a regulated environment. C/C++, Qt GUI development environment.
Must be well versed in 21CFR Part 820.30 and IEC62304, and have been an active team member and participant in at least one full concept-to-market medical device development cycle including use of version control software, code archival and reconstruction, bug tracking, verification and validation and follow-up on field issues and improvements. Working knowledge of modern high-speed RF data acquisition (DAQ) systems based on PCIe or other bus standards. Knowledge of algorithms and the mathematical constructs involved in high-speed data analysis and display including resampling, windowing, interpolation, fast Fourier Transforms (FFT) and optimization for display.
Proficient in written and verbal communication with attention to detail. Broad knowledge of medical device and standard computer systems including selection of appropriate platforms and suppliers for hardware. Working knowledge of Microsoft Office Products. An ability to work independently, establishing work priorities and direction. Analyzes complex issues and presents to senior management with recommendations for action. Ability to evaluate and analyze procedural gaps Ability to react constructively in a high-energy and fast paced environment
Preferred: Project management skills including MS Project with the ability to align and balance potentially conflicting internal and external resources. Experience working with tablet displays and wireless streaming, and/or AR systems, particularly the Microsoft HoloLens device. Ability to read electronic schematics and datasheets. Practical EE debugging skills using oscilloscopes etc. Labview / MatLab / Python desirable.
Principals only please
Applicants must be authorized to work in the U.S.
To apply click HERE.
Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Right to Work In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.