Senior Engineer, Product Design

ICU Medical • San Clemente, CA

19d • $105,000 - $150,500

About The Position

The Senior Engineer supports Research and Development and Strategic Business Development 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. Work involves plastics engineering, polymers, molding, medical disposables, and solid modeling, with direct interaction 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, applies specialized knowledge and skills, independently resolves technical issues related to project or product needs, and selects methods for solving diverse, non-routine problems. Technical guidance may be provided for unusual or particularly complex problems. Work may result in new or refined equipment, materials, processes, products, or methods.

The position is largely sedentary, operates in a professional office environment, and routinely uses standard office equipment. Travel is typically less than 5% of the time. The salary range is $105,000–$150,500 in annual base salary; actual pay 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.
• At least 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 for various product lines 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; support 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 according to 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.

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.

What This Job Offers

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