Engineer I, Product Design

ICU Medical • San Clemente, CA

2d

About The Position

The Product Design Engineer supports the Business Development R&D department by developing and implementing new products in accordance with established design control processes and good engineering and documentation practices. The role focuses on designing, developing, and improving ICU Medical’s product portfolio to promote efficiency and reliability, with significant involvement in plastics, polymers, molding, medical disposables, plastics engineering, and solid modeling. The engineer primarily interfaces with internal customers and external suppliers on the design and configuration of high-volume disposable medical devices, and contributes to addressing development and compliance challenges for new medical devices. The position interacts with functional groups including Marketing, Regulatory, Quality, and Operations.

Requirements

• 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.
• SolidWorks competency.
• 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.
• Understanding of engineering mechanics and physics.
• Detail-oriented, with the ability to organize large amounts of work and data.
• Strong verbal and written communication, customer focus, time management, professionalism, coaching, influencing, and team-building skills.
• Project leadership skills and ability to expedite project completion.
• Must be at least 18 years of age.

Nice To Haves

• Master’s degree preferred.
• Familiarity with machine shop practices.
• Familiarity with drafting standards.

Responsibilities

• Assist in developing products from concept through production.
• Develop product requirements based on customer and business needs and 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 product success.
• Provide technical support on components, materials, methods, systems, and equipment.
• Provide technical foundations for risk documentation.
• Develop test procedures to verify specifications and regulatory requirements.
• 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

• Competitive financial benefits, including a generous 401(k) match and, for eligible roles, an Annual Incentive Plan.
• A wide range of benefit options at affordable rates.
• Paid Time Off.
• Company Holidays.
• Tuition Reimbursement.
• Health and welfare benefit offerings.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level