Job Description

KEY RESPONSIBILITIES

• Design, Developing and debugging for electro-mechanical medical devices.
• Developing required documentation, design history files for the electro-mechanical devices.

WHAT IS EXPECTED OF YOU AND OTHERS AT THIS LEVEL

• Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects.
• Recommends new practices, processes, metrics, or models.
• Works on or may lead complex projects of large scope.
• Provides solutions which may set precedent.
• Independently determines method for completion of new projects.
• Receives guidance on overall project objectives.
• Acts as a mentor to less experienced colleagues.

QUALIFICATIONS

• Bachelor’s degree or equivalent experience in related field preferred (Computer Engineering, Electrical Engineering, etc.)
• A minimum of 6+ years related work experience preferred

TECHNICAL SKILLS PREFERRED

• Software development in an RTOS environment.
• Software development for mechatronic systems.
• C, C++, Python, Java, Microsoft Visual Studio, .NET.
• Web development experience.
• Electronic circuit design to the schematic level.
• Experience working in a medical environment to the ISO 13485 standard.
• Knowledge of IEC 62304 – Medical Device Software Standard and the application of Risk Management per ISO 14971.
• Experience with Wireless (Zigbee, Wi-Fi, 3G) a plus.
• Knowledge of IEC 60601 3rd Edition Standard.
• DFSS or Six Sigma/Lean Certification.