Engineer III, Product Design at ICU Medical, Inc. in San Clemente, California

Job Description:

Responsibilities



Assist in the development of products from concept to production. Responsible for the design of new products for IV Therapy, Oncology and Critical Care Consumables. Works with Marketing and Sales teams to understand the customer needs and translate the needs into new product designs that will meet customer and regulatory requirements. The devices range from Class I to Class III depending on the device with devices such as Administration Sets, Needlefree Connectors, Closed System Transfer Devices and Pressure Monitoring Kits. Determine the appropriate product requirements, develop test methods to evaluate product performance and create mechanical designs for components and assemblies to deliver a finished medical device. Once design is fully defined, works with the quality team to generate design verification and validation data that substantiates the product safety and performance. Interface with manufacturing to ensure the correct translation of design outputs into production specifications and as a subject matter expert, provides guidance for resolution of product defects and implementation of risk controls. Develop product requirements according to customer and business needs in compliance with international standards and regulations applicable. Adhere to established design control processes and good engineering practices. Design and model components and devices for various product lines (Infusion Sets, Vial Adapters, Closed System Transfer Devices, Luer Activated Valves and other consumables) using SolidWorks. Evaluate parts, products, or processes for efficiency and reliability to ensure long-term success of new / improved product lines. (As needed for improved product performance, manufacturability, usability and quality). Provides technical support on components, material methods, systems and equipment. (Provides direction for the selection of manufacturing equipment, test methods and materials needed to achieve product performance success). Provides the technical foundation for the development of risk documentation. (As a product subject matter expert provides definition of design features, usability and hazards associated with the device). Develops test procedures to ensure specifications and regulations are met. (Definition of measurement equipment, design of test fixtures and determination of standard operating procedures for the performance of product test that substantiates product safety and performance). Writes, reviews, and approves protocols, reports and data. Conducts testing outlined in protocols and test methods. Executes engineering and validation studies on products. Conducts failure investigations. Provides support for high impact complaints to identify product or manufacturing flaws and proposes solutions to prevent failure modes from re-occurring. Work on special projects as assigned. Provides support for strategic initiatives driven by commercial leadership to expand the product portfolio, improve operational efficiencies and/or where product and manufacturing expertise are needed. *Hybrid work is permitted. When not working from home, must report to San Clemente, CA office*



EDUCATION AND EXPERIENCE REQUIREMENTS:



Bachelor's degree (or foreign equivalent) in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or related field plus Four (4) years of experience in Medical Device Product Development, in the job offered, or related occupation.



SPECIAL REQUIREMENTS:



Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be "quantified" by "time." Required expertise/knowledge includes: Knowledge of medical device manufacturing practices; Knowledge of medical grade plastics and general injection molding principles; Knowledge in joining methods of plastics (Solvent, Ultrasonic, etc.); Experience with design of experiments (DOE) and basic statistical methods; Competency in SolidWorks; Understanding of engineering mechanics and physics; Familiarity with machine shop practices (all hand and machine shop tools); Familiarity of drafting standards such as GD&T.

ICU Medical, Inc. is an equal opportunity employer.

Job Location: 951 Calle Amanecer, San Clemente, CA 92673

40 hours per week / $108,680 - $118,250 per year


If offered employment, must have legal right to work in U.S.


To apply for ICU Medical's Engineer III, R&D Product Engineering position please send resume to: humanresouces@icumed.com.

Must reference JOB CODE: CA0324AV




EOE M/F/D/V
It is the policy of ICU Medical, Inc. to afford full equal employment opportunity to qualified employees and applicants, regardless of their race, color, religion, sex, national origin, age, physical or mental handicaps, military or veteran status, sexual preference, or any other protected condition or characteristic in conformity with all applicable federal, state and local laws and regulations.