Principal Systems Engineer - Embedded(HYBRID - Open to Relocation)
Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to develop software.
Motivated product launchers. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
Lead technical team members in the design, development, modification, and evaluation of design modules, sub-systems, or assemblies.
Translate user needs to design inputs/ specifications and produce architectural-level layouts and platform designs.
Able to architect an entire complex system, defining interfaces and dependencies between components. Easily solves complex system-level issues.
Lead and mentor teams to solve significant and unique issues where analysis of situations or data requires evaluation of minimally defined problems.
Work on the system aspects of a robotic system platform with customers across the globe.
Design, write and deploy robotic system hardware, software, and firmware while meeting company quality expectations for effectiveness, reliability, and safety.
Design, write and deploy subsystem test platforms and protocols.
Interact with internal customers and marketing to draft/update customer, system, and subsystem requirements.
Coordinate with mechanical, electrical, software, and system engineers to ensure that the system and subsystems designs meet specified requirements.
Analyze system and subsystems requirements to ensure they are clear and verifiable, and that traceability of requirements is accurately captured and documented.
Incorporate post-market data into designs with targeted precision.
Collaborate in the development and execution of plans, protocols, and reports for verification and validation (V&V).
Use common software tools, such as SolidWorks for CAD/CAM, Minitab for statistical analysis, and MATLAB for analysis through scripting.
Apply FDA regulatory guidance, such as ISO 13485 / 14971 / 62304, to biomedical device development.
Collaborate with Quality Assurance in analysis for the device risk management file, including failure modes and effects analysis (FMEA) and fault tree analysis (FTA).
Collaborate with technical writers to create and revise documentation.
Possess an in-depth knowledge of the industry and competitive landscape
Partner with customers, internal and external key opinion leaders to develop technical strategies that meet clinical needs
Strategize and execute customer-facing activities like the voice of customer and customer-centric design across the business
Collaborate on Financial /business modeling and support business reviews to validate a technical approach
Lead cooperative efforts to ensure the design meets the needs of all stakeholders
Lead and support team members to create or improve procedures, policies, processes, systems, and technology requirements
Identify and implement design and process solutions and ensures they are sustained over time
Hold team accountable to deliver high quality results with passion, energy, and drive to meet business priorities
Mentor, develop and influence across the business, intentionally building divisional relationships
Bachelor of Science in Software, Electrical, Mechanical, Systems, or Biomedical Engineering & 8+ years of work experience
Ability to communicate complex plans and technical information to team members within and across businesses
Develop and utilize tools to enhance the company’s product/process development or performance
Requirements management tools, such as JAMA, Integrity, or DOORS.
Experience managing product defects using tracking tools such as Jira.
Experience with embedded development using C, C++, Python programming languages.
Proficient in scripting and analysis using MATLAB.
Proficient in statistical analysis with Minitab leveraging data analysis to drive decision-making
Broad base of experience in implementing design methodologies such as DFM, Reliability and Systems Design
High degree of experience in medical device design (or designing in a highly regulated industry) and ability to utilize Requirements Management Tools and System Modeling Tools
3D CAD/CAM software, such as SolidWorks or Creo, etc.
EDA software, such as Altium.
Experience with SysML and Model-based Systems Engineering
Experience with SysML / MBSE software tools
Divisional expert with extensive experience applying industry standards for device development
Independent reviewer and advisor for the creation or refinement of engineering documentation, such as the Design History file
Lead the development of standards and regulations, working closely with functions within and across business
