Systems Engineer

About This Role

Responsible for system level design of complex implantable medical device systems by developing system requirements from user needs and stakeholder inputs, designing and documenting system architecture and guiding the implementation of system features through hardware/firmware/software development and verification activities.  Provides support for other system design activities using systems engineering principles and technologies.

Your Responsibilities Will Include

• Applying critical thinking skills to solve systems interaction problems 
• Utilizing architecture design tools to develop and document system-level interactions
• Creating design documentation such as requirements rationale, requirements tracing, system change analysis within our quality system
• Writing reports for and working with internal regulatory team to satisfy the requirements for external regulatory agencies
• Utilizing multiple version control, defect tracking, and peer review tools including Accurev, JIRA and Windchill to document your work within our quality system

Required Qualifications

• Bachelors (5+ years experience) or Masters (3+ years experience) in Electrical Engineering, Computer Engineering, Computer Science or related fields
• Understanding and experience in the design, development, and testing of embedded systems and/or and active implantable medical devices
• Ability to interpret and develop system requirements and system specifications
• Experience with general electronic bench test equipment: oscilloscopes, DMM's, Data Acquisition devices
• Experience developing code in Python, C/C++, Java or Assembly

Preferred Qualifications

• 3+ years experience in systems, software or electrical hardware engineering.
• 2+ years experience in system development lifecycle process including formalized processes and procedures
• Ability to interpret and apply regulations and standards relevant to class II/III medical devices
• Familiarity with requirements management/PLM tools
• Experience in product concept development, customer interaction, verification of engineering requirements, and validation of customer needs/design requirements
• Strong written and verbal communication, judgment, decision-making, and critical thinking skills
• Ability to build relationships across the organization and with external stakeholders
• Practical knowledge of project management concepts and exposure to Agile methodologies