Senior Engineer, Software Systems at ICU Medical, Inc. in San Diego, California

Job Description:

Job Description



This is a senior engineering role that is expected to be experienced in the development and maintenance of secure networked medical products. This role will be accountable for timely delivery of multiple major engineering deliverables and projects.



Essential Duties & Responsibilities


Act as a Software Systems Engineer for the product with the following responsibilities:

• Delivery of Software Systems Engineering portions of the Design History File such as System Requirements, Subsystem Requirements, Use Cases, Trace Matrix, etc.
• Work with the Risk Management Team to help build and maintain the Risk Management File
• Participate in 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

• Experience with infusion pump user interface design is a plus
• Experience with infusion pump clinical workflows is a plus
• Experience with UML and/or SysML is a plus
• Experience with MBSE using tools such as Magic Draw or similar is a plus
• Experience developing product requirements and design inputs required
• Experience with hazard analysis and assurance cases is a plus
• 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 with medical devices is a plus

Minimum Qualifications, Education & Experience

• 7+ years of experience in software development with at least
• 2 years of experience in requirements management

Salary Range - $105,000 - $150,500

The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.



About Us



ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:


ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement


OFCCP Equal Opportunity Posters

• "Know Your Rights" Poster
• Pay Transparency Nondiscrimination Provision

ICU Medical CCPA Notice to Job Applicants Apply Now