Position Summary// The Product Design Engineer will support the Business Development R&D department. The engineer is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices.The key responsibility of this position is to design, develop, and improve ICU’s product portfolio to ensure their efficiency and reliability. The incumbent will be heavily involved with plastics, polymers, molding, medical disposables, plastics engineering, and solid modeling. The R&D Product Engineer will be expected to interface mainly with internal customers and external suppliers on the design and configuration of high-volume disposable medical devices. The position plays a key role in assisting in the development and compliance challenges involved with new medical devices. The position requires the ability to interact with multiple functional groups such as Marketing, Regulatory, Quality, Operations, etc. * * Essential Duties & Responsibilities * Assist in the development of products from concept to production * 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 using SolidWorks * Evaluate parts, products, or processes for efficiency and reliability to ensure long-term success of new / improved product lines * Provides technical support on components, material methods, systems and equipment * Provides the technical foundation for the development of risk documentation * Develops test procedures to ensure specifications and regulations are met * 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 · 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, coaching, influencing, and team building. * Knowledge of medical device manufacturing practices * Knowledge of medical grade plastics and general injection molding principles * Strong knowledge in joining methods of plastics * Experience with design of experiments (DOE) and basic statistical methods * Excellent project leadership and ability to expedite project completion* * SolidWorks competency required * 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.  * 2-4 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 Salary Range: $68,000-$91,375k o The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location. ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Title: Engineer II, Product Design Location: CA-San Clemente Requisition ID: 24300593