The QiG Cardiovascular team is looking for a Firmware Engineer who will be responsible for the design, development and qualification of software and embedded firmware design elements of a new medical device system. The Engineer will successfully organize work activities and priorities in order to meet l program goals; Serve as a technical resource to cross functional team members; Responsible for specification development, generating project plans including schedule and budget, and development of software programs within an ISO 13485 development system.
- Analyzes, develops and creates software or firmware for implantable and external medical products following established design control procedures.
- Research, generate and document intellectual property; Identification and development of relevant software tests and specifications.
- Interact with customers and suppliers to assure product and project requirements are fulfilled.
- Work with project engineers to define product requirements.
- Drive the software and embedded firmware through the full development life cycle including product definition, specification, development, testing and post-release support.
- Specification development, project planning, customer interaction, implementation of software design activities for implantable medical devices, project management, and design verification/validation.
- Work on a mix of software and embedded firmware with both internal and external development partners.
- Create detailed firmware design documents and firmware descriptions.
- Present design implementation and algorithm approaches to internal/external groups.
Minimum Education: Bachelor’s degree in Computer Science, Electrical or Software Engineering. Master’s
Minimum Experience : 5+ years of hands-on design experience with a minimum of 2 years in the medical device or similarly regulated industry.
Specialized Knowledge: Fluent in C++ and C; Experience in C#, Python, Perl, XML and developing embedded software in a real time operating
system; ability to establish system requirements, system design and prototyping, verification, validation, risk analysis/FMEA and system testing;
working knowledge of GMP, ISO, and FDA regulations; Experience in designing and mapping complex software development systems.
Special Skills : Root cause analysis and critical thinking; ability to work in a team environment; presentation, interpersonal, communication, follow through and organizational skills; ability to analyze data using statistical methods.
Other : Experience with LabView, Matlab, database development, FPGAs, reliability and statistical software a plus.
Greatbatch - 10 months ago