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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Staff Software Engineer
Lawrence, MA
Fresenius Medical Care
Posted 11/12/2024
$81,000.00-$117,000.00 per year