Senior Member, Technical Staff - R&D Icu Medical
San Diego, CA

Job Description

The Senior Member, Technical Staff, Systems Engineering role will be responsible for leading the team defining and maintaining the system requirements for ICU Medical's cloud-based safety software. This role will execute key design engineering activities to support new product development and on-market engineering projects for the product. This role will identify and implement improvements in the Systems Engineering design processes and tools.

This is a senior engineering role that is expected to be highly experienced in the development and maintenance of secure networked medical products. This role will be expected to lead and mentor less experienced Systems Engineers to encourage their development in the area. This role will be accountable for timely delivery of multiple major engineering deliverables and projects.

Essential Duties & Responsibilities

* Act as the Lead Systems Engineer for the product with the following responsibilities
* Active participation in the Core Team as the Systems Engineering representative
* Delivery of the Systems Engineering portions of the Design History File
* Support the Risk Management Team to help build and maintain the Risk Management File
* Oversee the maintenance of the risk management and testing traceability
* Support the timely completion of product releases and design changes
* Contribute to the improvement of engineering design methods and processes
* Support FDA and other regulatory audits of product design history and technical files
* Work on special projects as they arise

Knowledge, Skills & Qualifications

* Experience with AWS-based development required
* Experience with Single Page Web Applications development required
* Experience with networking is a plus
* Experience with cybersecurity is a plus
* Experience in Software Development using a modern programming language such as Java/JavaScript/Python/C#/C is a plus
* Experience working on the architecture of a large-scale cloud-based system required
* Experience developing product requirements and design inputs required
* Experience with UML and/or SysML required
* Experience with medical devices is a plus
* Experience with IOT devices is a plus
* Experience with MBSE using tools such as Magic Draw or similar is a plus
* Experience with hazard analysis and assurance cases is a plus

Education and Experience

* Minimum of 15 years of experience in software development with at least
* 3 years of experience developing on AWS
* 2 years of experience in requirements management
* 5 years of hands-on programming experience
* 3 years working on medical devices or similar industries with high regulatory burdens such as aerospace or defense
* Bachelor's degree in software engineering from an accredited college or university
* Advanced degree in related fields is preferred

Minimum Qualifications

* Must be at least 18 years of age
* Must pass pre-employment drug screen and background check

Travel Requirements

* Typically requires travel less than 25% of the time

Physical Requirements and Work Environment

* This is largely a sedentary role.
* This job operates in a professional office environment and routinely uses standard office equipment.

Physical Requirements and Work Environment

* While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating
* Operator is required to use computer or touch screen to enter work order data
* Must be able to occasionally move and lift objects of up to 25 lbs.

We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.