Senior Engineer, Product Design

ICU Medical•San Clemente, CA

18d•$105,000 - $150,500

About The Position

The Senior Engineer supports Research and Development and Strategic Business Development activities by researching, developing, and implementing novel product concepts and designs in accordance with established design-control processes and good engineering and documentation practices. The role focuses on designing, developing, and improving product lines to ensure commercial viability, efficiency, and clinical reliability, with work involving plastics engineering, polymers, molding, medical disposables, and solid modeling. The position interfaces directly with clinicians, customers, academic and commercial research groups, and suppliers on complex technical and scientific topics. This is an individual-contributor role in a professional discipline or specialty. The engineer delivers and oversees projects from design through implementation, independently resolving technical problems and selecting methods and techniques for non-routine work. The work may result in new or refined equipment, materials, processes, products, or methods. Technical guidance may be provided for unusual or complex problems. The role is largely sedentary and operates in a professional office environment using standard office equipment. Travel is typically less than 5% of the time. The stated annual base salary range is $105,000–$150,500; actual salary may vary based on relevant experience, skills, education, licensure or certifications, and geographic location.

Requirements

At least 18 years of age.
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.
Knowledge of medical-device design controls and phase-gate product development processes.
Knowledge of medical-grade plastic manufacturing processes, injection-molding design principles, and common polymer-joining methods.
Knowledge of designing and modeling components and devices using SolidWorks.
Knowledge of clinical environments, including hospital and outpatient settings.
Experience with design of experiments (DOE) and basic statistical methods.
Excellent interpersonal and project-leadership skills, including the ability to expedite project completion.
Strong problem-solving, organizational, analytical, and critical-thinking skills.
Substantial understanding of engineering mechanics and physics.
Excellent computer skills, including Word, Excel, PowerPoint, and Project.
Familiarity with machine-shop practices.

Responsibilities

Lead and support product design and development from concept through the product life cycle.
Partner with marketing and commercial teams to understand business needs and translate them into actionable project-level tasks.
Analyze industry-related research and translate it into usable, marketable products and actionable strategies for long-term product visions.
Evaluate parts, products, and processes for efficiency and reliability to support the long-term success of new or improved product lines.
Write and review design-control and risk-management documents in accordance with company standards.
Incorporate applicable medical-device standards, including FDA, ISO, IEC, and EN requirements.
Provide solutions and guidance for technical issues and small projects as they arise.
Interface with clinicians, customers, academic and commercial research groups, and suppliers on complex technical and scientific topics.