Engineer I, Product Design

ICU Medical•San Clemente, CA
•$60,000 - $80,000

About The Position

The Product Design Engineer will support the Business Development R&D department by developing and implementing new products according to established design control processes and good engineering and documentation practices. The role focuses on designing, developing, and improving ICU Medical’s product portfolio to ensure efficiency and reliability. Work involves plastics, polymers, molding, medical disposables, plastics engineering, and solid modeling, with a focus on high-volume disposable medical devices. The engineer will interface primarily with internal customers and external suppliers on product design and configuration, contribute to new medical-device development and compliance, and collaborate with functional groups including Marketing, Regulatory, Quality, and Operations. The position requires a Bachelor of Science degree in Mechanical Engineering or a related field and 0–2 years of experience in medical device product development. A master’s degree is preferred. The stated annual salary range is $60,000–$80,000; actual pay may vary based on factors including experience, skills, education, certifications, and location.

Requirements

  • 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.
  • 0–2 years of experience in medical device product development.
  • Detail oriented, with the ability to organize large amounts of work and data.
  • Strong interpersonal skills, including verbal and written communication, 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 of plastics joining methods.
  • Experience with design of experiments (DOE) and basic statistical methods.
  • Project leadership skills and ability to expedite project completion.
  • SolidWorks competency.
  • Understanding of engineering mechanics and physics.
  • Familiarity with machine shop practices.
  • Familiarity with drafting standards.

Nice To Haves

  • Master’s degree.

Responsibilities

  • Assist in developing products from concept through production.
  • Develop product requirements based on customer and business needs in compliance with applicable international standards and regulations.
  • Follow established design control processes and good engineering practices.
  • Design and model components and devices for various product lines using SolidWorks.
  • Evaluate parts, products, and processes for efficiency and reliability to support long-term success of new and improved product lines.
  • Provide technical support related to components, materials, methods, systems, and equipment.
  • Provide technical foundations for risk documentation.
  • Develop test procedures to ensure specifications and regulations are met.
  • Write, review, and approve protocols, reports, and data.
  • Conduct testing specified in protocols and test methods.
  • Execute engineering and validation studies on products.
  • Conduct failure investigations.
  • Work on special projects as assigned.

Benefits

  • Generous 401(k) match.
  • Annual Incentive Plan for eligible roles.
  • A wide range of benefit options at affordable rates.
  • Paid Time Off.
  • Company Holidays.
  • Tuition Reimbursement.
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