Bachelor’s degree in Electrical Engineering or Computer Science with at least 5 years of work experience, OR Master’s degree in Electrical and at least 3 years of technical engineering professional experience
Demonstrated experience writing, documenting, troubleshooting, and releasing embedded code
Experience developing code for mid-to-large embedded or real-time applications, with responsibility for designing and implementing solutions that are currently in commercial use
Demonstrated problem solving skills – ability to analyze issues, design requirements and propose solid engineering solutions that meet business requirements
Ability to generate technical documentation such as product requirements, specifications, risk matrix, project schedules, engineering reports, test plans & procedures, validation plans, or validation reports
Experience developing products in a highly regulated industry such as medical devices
Experience within the medical device space highly desirable
Experience with a class II medical devices also highly desirable
Demonstrated experience with complex electro-mechanical systems
Good written and communication skills
Demonstrated ability of working on multiple simultaneous projects in a deadline driven matrix environment
Ability to develop a plan, come up with realistic schedules and meet timelines for software development
Adheres to safety and regulatory policy and procedures
Desirables
Experience in medical devices
Experience with class II medical devices
Complex electro-mechanical systems experience
What the job involves
Embed programming of medical device products from concept to implementation while ensuring full documentation of the process
Develop embedded, real-time software for Pentax Medical embedded products
Systemically design, develop and implement high quality software in C, C++ and include implementation of various types of algorithms and GUI elements
Analyze cases and document software requirements specifications and software design documents
Conduct code-review for individual and collaborative software
Investigate new technologies for medical device utilization
Define, plan, and conduct formal technical design and test reviews
Lead and apply risk management tools including risk matrix, risk impact/probability charts, FMEA, PFMEA, to software
Guide, develop, and review software verification strategies to test designs
Effectively communicate and work with all levels of the organization
Multi-task and prioritize work based on the shifting needs of the organization
Leverage appropriate tools such a MS PowerPoint and Project to communicate, plan, implement, and track projects
PENTAX Medical is a division of HOYA Group, committed to enhancing patient care and healthcare quality by offering top-tier endoscopic products and services. Emphasizing quality, clinically relevant innovation, and simplicity, it leverages cutting-edge R&D and manufacturing to deliver endoscopic imaging solutions worldwide.