Medical Staff Credentialing Manager jobs in Lawrence, MA

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