Senior Engineer, Product Design at ICU Medical, Inc. in San Clemente, California

Job Description:

Job Description



Position Summary


The Senior R&D Engineer will play a critical role in driving the design, development, and implementation of medical devices. This role involves collaborating closely with cross-functional teams-including marketing, commercial, quality, regulatory, and medical groups-to ensure that all product designs meet regulatory standards and customer expectations.

As a subject matter expert (SME) in medical device development, the Senior R&D Engineer will lead key projects of significant complexity while applying sound engineering principles, experimental methods, and analytical techniques. The ideal candidate will bring extensive hands-on experience in medical device design and development, with a strong background in documentation, testing, and risk management.



Essential Duties & Responsibilities

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  Lead Design Control Activities: Oversee all aspects of design control, including Requirements Management, Design Outputs, Verification & Validation (V&V), Design History File (DHF), and Risk File management.
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  Drive Product Development: Plan, design, and implement new products, ensuring compliance with applicable medical device standards.
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  Solve Complex Engineering Challenges: Apply experimental, computational, and analytical methods to address technical challenges and ensure product performance.
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  Develop and Maintain Technical Documentation: Create and maintain product specifications, requirements, architecture, design, and usability documents.
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  Conduct and Oversee Testing: Design and execute exploratory, bench, and V&V testing, developing test protocols and generating comprehensive reports.
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  Collaborate with Cross-Functional Teams: Partner with marketing, quality, and regulatory teams to ensure design requirements align with business objectives and regulatory compliance.
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  Design & Model Devices: Utilize SolidWorks to create and refine device models for various product lines, with a focus on high-volume disposable medical devices.
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  Partner with Suppliers & Customers: Collaborate with customers and suppliers to refine designs and ensure manufacturability, with an emphasis on plastics/polymer engineering and injection molding.
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  Mentor & Provide Technical Leadership: Act as a technical consultant, providing guidance on engineering best practices and mentoring junior engineers.

Knowledge & Skills

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  Proven Expertise in Medical Device Design: Extensive hands-on experience developing and improving medical devices, including knowledge of FDA regulations and ISO standards.
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  Proficiency in SolidWorks: Strong capability in 3D modeling and design for manufacturability.
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  Material & Manufacturing Knowledge: Deep understanding of medical-grade plastics, injection molding principles, and common joining methods.
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  Analytical & Problem-Solving Skills: Strong ability to apply statistical methods, including Design of Experiments (DOE), to solve complex engineering problems.
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  Strong Communication & Collaboration Skills: Ability to effectively communicate with technical and non-technical stakeholders across departments.
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  Knowledge of Engineering Mechanics & Physics: Solid understanding of the principles underlying mechanical design.
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  Familiarity with Machine Shop Practices: Understanding of basic machining operations and drafting standards.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• Bachelor's degree Mechanical Engineering or a related field from an accredited college or university is required
• Minimum of 7 years of relevant experience in medical device design and development.

Work Environment

• Primarily operates in a professional office environment with standard office equipment.
• This role is largely sedentary but may involve occasional visits to labs or manufacturing facilities.
• Travel is expected to be less than 5% of the time.

About Us



ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:


ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement


OFCCP Equal Opportunity Posters

• "Know Your Rights" Poster
• Pay Transparency Nondiscrimination Provision

ICU Medical CCPA Notice to Job Applicants Apply Now