Job Description
Position Summary
The Product Design Engineer I position in the Vascular Access Product Design Engineering team will have the opportunity to create impactful solutions for the medical field while collaborating with Product Development Engineers, Systems Engineers, R&D Testing Labs, Marketing, Design Assurance, as well as internal and external Manufacturing teams. The primary focus of this role will be supporting both early innovation and the identification of emerging technologies, as well as the development and design verification of medical device components and products of varying complexity. The engineer will require the ability to organize and run engineering studies, interest in running product design and technology focused research, the ability to run competitive product and characterization studies, and the ability to run design verification and product qualification on small to medium scope projects. The engineer is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices. The position plays a key role in assisting in the development and compliance challenges involved with new medical devices. Familiarity with Minitab and Solidworks, or comparable statistics and CAD software, is a plus.
Essential Duties & Responsibilities
- Organizes and executes engineering studies of small to medium complexity
- Conducts product design and technology focused research
- Runs competitive product and characterization studies
- Organizes, plans, and executes formal design verification activities for small to medium scale new product introduction projects. Supports similar activities for other projects of varying scale.
- Writes test protocols, performs test method validations and executes test plans, and authors test reports with data analysis and technical conclusions.
- Supports risk management activities through hazard analysis and design failure and effects analysis (DFMEA) and the identification and implementation of risk mitigation.
- Work on special projects as assigned
- Supports the analysis and evaluation of solutions to complex problems. Conducts investigations of varying complexity pertaining to the development of new designs, methods, materials or processes, and investigates possible applications of the results.
- Assists in the development of products from concept to production
- Adheres to established design control processes and good engineering practices
- Designs and models components, devices, test fixtures, prototype/pilot tooling for various product lines using SolidWorks
- Supports the technical foundation for the development of risk documentation
- Develops test procedures to ensure specifications and regulations are met
- Executes engineering and validation studies on products
Knowledge & Skills
- Detail oriented and ability to organize large amounts of work and data
- Strong interpersonal skills required in the areas of verbal and written communications, customer focus, time management, professionalism, and team building
- Excellent project leadership and ability to expedite project completion
- SolidWorks competency preferred
- Minitab or similar statistics competency preferred
- Understanding of engineering mechanics and physics
- Familiarity with machine shop practices
- Familiarity of drafting standards
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age
- Bachelor of Science degree from an accredited college or university in Mechanical Engineering or a related field. Master's Degree preferred.
- 0-2 years of experience in Medical Device Product Development
Work Environment
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Typically requires travel less than 5% of the time
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
