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Mid - Principal Environmental Engineer
4 months ago
Hybrid
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
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