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

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.