Job Description
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.
ICU Medical EEO Policy Statement
OFCCP Equal Opportunity Posters
- “Know Your Rights” Poster
- Pay Transparency Nondiscrimination Provision
ICU Medical CCPA Notice to Job Applicants
