Senior System Engineer (with Medical Devices Experience)

Translate customer requirements into system requirements and interface definitions

Establish architecture design and decompose the system into lower-level building blocks

Assess the feasibility of technology and contribute to technical concepts

Perform functional analysis and create system designs to meet requirements

Contribute to high-level technical planning, supplier work package definition

Lead system integration and system testing of prototypes

Initiate preliminary hazard analysis and establish the risk management plan

Lead FMEA (Failure Mode and Effects Analysis) on the system 

Create a master verification plan for product and manufacturing requirements

Ensure traceability between requirements, test cases, verification, and reports

Organize technical reviews, contribute to design reviews and milestone reviews

Generate intellectual property

Work with Quality, Regulatory, Clinical, and Project Management on formal product development processes

Own the product development lifecycle, including maintenance and service

Guides the development team in manufacturing process qualifications and validations

Bachelor's or Master's degree in a relevant engineering discipline

Relevant industry experience of at least 5 years in medical devices or another highly regulated environment

Strong engineering background (e.g., mechanics, electronics, software) with a generalist view of system engineering

Experience in delivering complete systems to market (preferably active implantable medical devices)

Preferably experience with the development of active implantable medical devices

Experience with DRM/DFT (Design for Reliability, Manufacturing, and Test)

Familiarity with agile processes, continuous development, continuous integration, and test automation

A high-energy, self-motivated, and pro-active individual able to work in a diverse team in a startup company.  

Good analytical skills

Reliable, pragmatic, and result-oriented

Good communication and presentation skills

Fluency in English

Spanish is a nice to have