The Systems Engineer II will make an immediate impact defining ICU Medical's current and next generation infusion pumps to meet user and stakeholder needs with guidance from more experienced engineers and managers. The successful candidate will have the following traits:
Experienced in System Engineering techniques
Experienced in the development and maintenance of life supporting medical products
Able to work independently with minimal supervision
Able to collaborate effectively with marketing, medical, regulatory, and R&D team members
Utilize a growth mindset to continuously improve our Systems Engineering capabilities.
Essential Duties & Responsibilities
Timely delivery of system engineering deliverables to support the execution of development projects including user and stakeholder needs, system requirements, hardware subsystem requirements, and hardware dFMEAs.
Maintenance of requirements and traceability in requirements management tools
Continuously improve Systems Engineering methods, processes, and tools
Support FDA and other regulatory audits of product design history and technical files
Knowledge & Skills
Systems thinking
Requirements definition and decomposition
System and hardware architecture definition and design
Requirements management tools such as MagicDraw or DOORS
Risk Management
Model based system engineering (MBSE), UML and/or SysML is a plus
Lean-Agile development methodologies is a plus
Knowledge of medical device software life cycle processes is a plus
Experience with drug infusion pumps is a plus
Minimum Qualifications, Education & Experience
Must be at least 18 years of age
Bachelor's degree in mechanical, electrical, systems, biomedical or similar engineering discipline from an accredited college or university
Advanced degree in related fields is preferred
Minimum of 2 years of experience in systems development or related experience
Work Environment
This position requires being on-site a minimum of 3 days per week.
This is largely a sedentary role.
This job operates in a professional office environment and routinely uses standard office equipment.
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.
Typically requires travel 5-20% of the time
Salary Range - $72,150 - $102,125
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.