Job DescriptionPosition Summary The Engineer I, Product Design position in the Vascular Access Product Engineering team will have the opportunity to manage product design changes for post market product in the medical field while collaborating with Product Design 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 the post market development and performing design verification of medical device components and products of varying complexity. The engineer is responsible for developing and implementing design and development plans through adherence to established design control processes and good engineering and documentation practices. The position plays a key role in assisting in the supply continuity and compliance challenges involved with medical devices. Familiarity with Minitab and SolidWorks, or comparable statistics and CAD software, is a plus.
Essential Duties & Responsibilities - Organizes, plans, and executes formal design verification activities for small to medium scale design change 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.
- Supports the analysis and evaluation of solutions to complex problems. Conducts investigations of varying complexity pertaining to the change in designs, methods, materials or processes, and investigates possible applications of the results.
- Assists in root cause analysis and the development and implementation of solutions for non-conforming events through the Corrective Actions and Preventable Actions (CAPA) process.
- 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
- Develops test procedures to ensure specifications and regulations are met
- Executes engineering and validation studies on products
- Work on special projects as assigned
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
- Able to review and interpret technical documentation such as engineering drawings and component specifications
- SolidWorks competency preferred
- Minitab or similar statistics competency preferred
- Understanding of engineering mechanics and physics
- Able to analyze technical problems, develop creative solutions, and implement effective changes
- 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.
- Experience in Medical Device Product Development preferred.
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 UsICU 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 being an 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, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
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