Senior Medical Device Design Engineer

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

Benefits offered by this job

401(k) match

Tuition Reimbursement

Paid Time Off

Company Holidays

Job summary

ICU Medical, Inc. in California seeks a Senior R&D Engineer to advance product concepts through design controls, development, and robust documentation.

You will work on plastics engineering, molding, medical disposables, and solid modeling, interfacing with clinicians and suppliers. This is an individual contributor role focused on delivering projects from concept to deployment, applying FDA/ISO standards, DOE approaches, and SolidWorks modeling to ensure product viability, reliability, and

Qualifications

• BS in Mechanical Engineering or related field.
• Minimum 6 years in Medical Device Product Development or Manufacturing Support.
• Familiarity with design controls and medical device standards.

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 translate core business needs into actionable tasks.
• Provide in-depth analysis to translate industry research into usable products and strategies.
• Evaluate parts, products, or processes for efficiency and reliability to ensure long-term success.
• Write and review design control and risk management documents according to company standards.
• Incorporate required medical device standards (FDA, ISO, IEC, EN).
• Provide solutions for technical issues and small projects as they arise.
• Knowledge of medical device design controls and phase gate product development.
• Knowledge of medical grade plastic manufacturing processes, injection molding design principles, and polymer joining methods.
• Knowledge of SolidWorks for component and device modeling.
• Familiarity with hospital and outpatient clinical environments.
• Experience with design of experiments (DOE) and basic statistical methods.
• Strong interpersonal and project leadership skills.

Job description

ICU Medical, Inc. in California seeks a Senior R&D Engineer to advance product concepts through design controls, development, and robust documentation.

You will work on plastics engineering, molding, medical disposables, and solid modeling, interfacing with clinicians and suppliers. This is an individual contributor role focused on delivering projects from concept to deployment, applying FDA/ISO standards, DOE approaches, and SolidWorks modeling to ensure product viability, reliability, and