Firmware Engineer
QiG Group - Plymouth, MN

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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.

Key Responsibilites:
  • 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.
Requirements:

Minimum Education: Bachelor’s degree in Computer Science, Electrical or Software Engineering. Master’s

preferred.

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 - 23 months ago - save job