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ICU Medical

IV therapy systems and safety solutions

Senior Engineer - Product Design

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timeSan Clemente, CA, USA

About the Job

Requirements

  • A Bachelor of Science degree from an accredited college or university in Mechanical Engineering or a related field is required.
  • At least 6 years of experience in Medical Device Product Development and/or Manufacturing Support Engineering is required.
  • Knowledge of medical device design controls and the phase-gate product development process is required.
  • Knowledge of medical-grade plastic manufacturing processes, injection molding design principles, and common polymer joining methods is required.
  • Knowledge of design and modeling of components and devices for various product lines using SolidWorks is required.
  • Knowledge of clinical environments, including hospital and outpatient settings, is required.
  • Experience with design of experiments and basic statistical methods is required.
  • Substantial understanding of engineering mechanics and physics is required.
  • Computer skills including Word, Excel, PowerPoint, and Project are required.
  • Familiarity with machine shop practices is required.
  • The role requires incorporating applicable medical device standards, including FDA, ISO, IEC, and EN.
  • The role requires problem-solving, organizational, analytical, and critical-thinking skills, along with interpersonal and project leadership skills.

Responsibilities

  • Research, develop, and implement novel product concepts and designs in accordance with established design-control processes and engineering and documentation practices.
  • Design, develop, and improve product lines to support commercial viability, efficiency, and clinical reliability.
  • Interface with clinicians, customers, academic and commercial research groups, and suppliers on complex technical and scientific topics.
  • Lead and support product design and development from concept through the product life cycle.
  • Partner with marketing and commercial teams to understand business needs and define actionable project-level tasks.
  • Analyze industry-related research and translate it into usable, marketable products; support actionable strategies for long-term product visions.
  • Evaluate parts, products, or processes for efficiency and reliability to support the long-term success of new or improved product lines.
  • Write and review design-control and risk-management documents according to company standards.
  • Provide solutions and guidance for technical issues and small projects as they arise.
  • Independently approach and resolve technical solutions related to project or product needs, selecting methods and techniques for non-routine problems.
  • Develop or refine equipment, materials, processes, products, or methods.
  • Travel less than 5% of the time, typically.

About the Company

ICU Medical

IV therapy systems and safety solutions

ICU Medical focuses exclusively on IV therapy across the care continuum. It develops and supplies IV therapy systems, software, and consumables designed to fit existing clinical workflows and improve patient safety and experience. Its product line includes dedicated and non-dedicated IV sets and needle-free connectors that reduce bacterial transfer, a broad range of IV smart pumps for large-volume, pain-management, and ambulatory use, and IV medication safety software that interoperates with IV-EHR systems to support safer, more efficient care. The company differentiates itself by being 100% focused on IV therapy (a result of acquiring Hospira Infusion Systems) with extensive manufacturing and supply capabilities and the broadest IV pump portfolio, enabling strong compatibility with many EHR systems. ICU Medical’s goal is to improve the safety and efficiency of IV therapy and strengthen the clinical experience for patients and caregivers.

Company size
5,001-10,000
Company stage
IPO
Headquarters
San Clemente, CA
Founded
1984

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