We are looking for a Systems Engineer to join our client in Cambridge, Ma on a direct hire basis. 

Roles and Responsibilities:

The Systems Engineer will be part of the the product development engineering team. The Systems Engineer will work with  electrical, mechanical, and software engineering teams to design, verify, and commercialize the drug delivery device.

• Work with electrical, mechanical, and software teams to design, debug, and verify/validate new and existing hardware.

• Emphasis on guiding  risk management process, from preliminary hazard analysis to the implementation of effective risk control measures and their verification.

• Prepare documentation and conduct testing in support of safety certification and notified body submissions. Interface with 3rd party test houses.

• Support transfer to manufacturing, including build support, failure analysis, root cause analysis, and product improvements • Work with  existing suppliers and new vendors who you will find and evaluate to obtain and qualify parts. 

Required Skills and Experience:

• At home in the medical device design and documentation processes. Familiar with ISO 13485 compliant quality management systems.

• Expertise in risk management and risk management process.

• Familiarity with IEC 60601. Experience with compliance testing and preparing documentation for certification.

•  Our product is a highly integrated electromechanical system, powered by a rechargeable lithium ion battery. The core of the electrical system is an ARM Cortex-M series microcontroller, with a generous helping of power electronics. Our firmware is written in C++ and runs on SafeRTOS. We use Python extensively for tools and automation.

Qualifications:

• B.S. in engineering preferred

• 4+ years of product development experience in the medical devices

• Excellent written and verbal communication skills

• The ideal candidate will derive genuine glee from working in the medical device industry. 

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