Senior Medical Device R&D Engineer

ICU Medical Inc; San Clemente (CA); On-site; USD 105,000 - 151,000; Full time

Job summary

ICU Medical Inc. is seeking a Senior R&D Engineer to support Research and Development and Strategic Business Development activities. You will research, develop, and implement novel product concepts with strict design controls and documentation practices.

You will lead product design, development, and improvement across lines to ensure commercial viability, efficiency, and clinical reliability, working with clinicians, customers, and suppliers on complex topics.

Qualifications

• Must be at least 18 years old.
• Bachelor of Science degree from an accredited college or university in Mechanical Engineering or a related field.
• Minimum 6 years of experience in Medical Device Product Development and/or Manufacturing Support Engineering.

Responsibilities

• Lead and support the design and development of products from concept and throughout a product life cycle.
• Partner with marketing and commercial teams to understand core business needs and drive actionable project level tasks to address those needs.
• Provide in-depth analysis to translate industry-related research into usable and marketable products and support actionable strategies for long-term product visions.
• Evaluate parts, products, or processes for efficiency and reliability to ensure long-term success of new / improved product lines.
• Write and review design control and risk management documents according to Company standards.
• Incorporate medical device standards (FDA, ISO, IEC, EN) into design and development.
• Provide solutions and guidance for technical issues and small projects as they arise.
• Knowledge of medical device design controls and phase gate product development process.
• Knowledge of medical grade plastic manufacturing processes, injection molding design principles, and polymer joining methods.
• Knowledge of SolidWorks for design and modeling of components and devices.

Skills

Strong problem-solving

Interpersonal and project leadership

Analytical thinking

Medical device design controls

Solid modeling

Education

Bachelor of Science in Mechanical Engineering

Tools

SolidWorks

MS Word

MS Excel

MS PowerPoint

MS Project

Job description

ICU Medical Inc. is seeking a Senior R&D Engineer to support Research and Development and Strategic Business Development activities. You will research, develop, and implement novel product concepts with strict design controls and documentation practices.

You will lead product design, development, and improvement across lines to ensure commercial viability, efficiency, and clinical reliability, working with clinicians, customers, and suppliers on complex topics.