Fresenius Medical Care North America • Lawrence, MA 01842
Job #2692934225
Position Summary
The individual in this role will support activities related to the design, development, and manufacturing of our equipment products.
Core Responsibilities
Lead major projects, or phases of projects
Resolve advanced and complex technical challenges
Create software architecture (embedded, O.S., and Application layer) for complex electromechanical devices · Software/sensor algorithm development and optimization and/or Machine Learning Algorithm development.
Perform Risk Analyses, including Fault Tree Analysis (FTA), Failure Mode and Effects Analysis (FMEA), and Cybersecurity Analysis in compliance with applicable standards
Lead Risk Management activities to ensure compliance with applicable design- and process-related standards
Lead the product development team in the adoption and use of best practice software design methodologies
Debug designs
Provide technical support for product development, as well as systems integration and testing
Investigate the feasibility of new projects, systems, or approaches
Mentor other engineers in good coding practices, debugging techniques, etc.
Work with Quality Assurance to maintain an approved internal Quality System that meets the requirements of GMP's, QSR, ISO 13485 , and IEC62304
Requirements
BS in Software Engineering, Electrical Engineering, or equivalent
MS/ME in relevant disciplines is strongly Preferred
10+ years of experience in software product engineering and development
· Hands-on technical leader/mentor for a team of senior and mid-level engineers.
· C and/or C++ Language Skills
· Must have Medical device or other safety critical device development experience
Able to generate thorough and comprehensible documentation - requirements through software, as well as risk documentation.
Experience with embedded systems development
Experience with sensors, CAN, A/D, embedded operating systems, multiple processor systems
Proven ability to run major software development projects from concept to manufacturing
Proven advanced technical knowledge in software development methodologies
Demonstrated expert analytical and design skills
Proven knowledge of project lifestyles, software development environments, and source control techniques
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