This is a senior engineering role that is expected to be highly experienced in the development and maintenance of medical products with specific expertise in electronics development. This role will be expected to 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.
The successful candidate will have the following traits:
Experienced in advanced System Engineering techniques such as model based system engineering
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.
Collaborate with the hardware development teams with a specific focus on electronics technology
Work with the Risk Management Team to help build and maintain the Risk Management File
Maintenance of requirements and traceability in requirements management tools
Support the timely completion of product releases and design changes
Continuously improve Systems Engineering methods, processes, and tools
Support FDA and other regulatory audits of product design history and technical files
Work on special projects as they arise
Knowledge & Skills
Product requirements and design input definition and decomposition
System and hardware architecture definition and design
Electrical engineering and electronics development
UML and/or SysML
MBSE using tools such as Magic Draw or similar is a plus
EMC expertise
Hazard analysis and assurance cases is a plus
Agile development methodologies is a plus
Minimum Qualifications, Education & Experience
Must be at least 18 years of age
Bachelor's degree in electrical, systems, or biomedical engineering from an accredited college or university
Advanced degree in related fields is preferred
Minimum of 10 years of experience in electrical hardware and/or systems development
2 years of experience in requirements management
5 years of hands-on electrical engineering experience
3 years working on medical devices or similar industries with high regulatory burdens such as aerospace or defense
Work Environment
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 - $123,750 - $177,375
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.