Description
Position Summary
The Engineer III position in the Vascular Access Product Engineering group is responsible for managing the post launch life cycle for products that have been released for sale. This includes analyzing change requests and creating and executing design and developments plans, investigating and correcting non-conforming events, including Corrective Actions and Preventative Actions, remediating design history files to conform to new regulatory requirements, and developing line additions to expand the scope of a product portfolio. The Engineer III works on projects/matters of advanced complexity and often works independently of senior engineering and managerial staff.
Essential Duties & Responsibilities
• Organizes, plans, and executes activities related to implementing design changes per design and development plans and company procedures.
• Writes test protocols, performs test method validations and executes test plans, and authors test reports with data analysis and technical conclusions.
• Updates design output documents such as engineering drawings, purchasing specifications, and bill of materials.
• Completes risk management activities through hazard analysis and design failure and effects analysis (DFMEA) and identifies and implements risk mitigation.
• Provides technical support to regulatory, sales, marketing and other functional areas as needed.
• Helps lead investigations of root causes leading to non-compliance events arising from design, manufacturing, procedural or customer use.
• Provides technical support as a Subject Matter Expert for a particular Product Line.
• Works on special projects as assigned.
Knowledge & Skills
• Able to solve technical problems using engineering principles and analytical ability using effective methodologies and best practices.
• Able to critically review and interpret technical documentation such as engineering drawings and component specifications.
• Able to work accurately with attention to detail.
• Able to handle multiple priorities and meet key deadlines under pressure through effective time management skills.
• Able to communicate professionally to technical and non-technical internal and external customers through conversations, presentations, and formal and informal electronic media.
• Able to build consensus across project or engineering teams with well-reasoned arguments in a collaborative effort to resolve conflicts or to develop new strategies.
• Able to act as a subject matter expert in a product or technical area and have a working knowledge in a related areas of expertise.
Minimum Qualifications, Education & Experience
• Must be at least 18 years of age.
• Bachelor's degree in mechanical or biomedical engineering from an accredited college or university is required.
• 4-7 years of work-related experience
• Position requires active and current compliance with all credentialing requirements, including COVID-19 vaccination, to perform the essential function of your role at customer locations.
Work Environment
• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office and laboratory equipment. Work from a home office may be allowed on a limited basis.
• As part of the scope of employment, the employee must hold a valid driver's license as well as comply and meet the requirements set forth in the Authorized Driver Policy to drive on behalf of the company.
• Typically requires travel 5%-20% of the time
What We Do
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables.
Since IV therapy is our only business, meeting your IV needs with quality products and consistent supply is our only concern. We are 100% focused on bringing you intuitive, patient-centric IV products and services that provide meaningful clinical differentiation, consistent innovation, and superior value. We design our products to work within your existing workflows to minimize disruption and maximize the time you spend with patients.
Together, we help forge the human and emotional connections that enhance clinical experience and are the essence of outstanding quality of care.
For more than three decades, we have been dedicated to a singular purpose—improving the safety and efficiency of IV therapy. With the acquisition of Hospira Infusion Systems from Pfizer in 2017, we became the only company to focus exclusively on IV therapy across the continuum of care.
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.
