Engineer I, Product Design

ICU Medical Inc; San Clemente (CA); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

401(k) match

Tuition Reimbursement

Paid Time Off

Job summary

ICU Medical Inc. is seeking a Product Design Engineer in California to support the Business Development R&D team. The role focuses on designing, developing, and improving the company’s medical device portfolio with emphasis on plastics, molding, and high-volume disposables.

You will work with cross-functional teams to ensure compliance with design controls and documentation standards. The ideal candidate will have a BS in Mechanical Engineering, 0–2 years in medical device product development,

Qualifications

• Bachelor's degree in Mechanical Engineering or related field required; Master's preferred.
• 0–2 years of experience in medical device product development.
• Experience with medical device design controls and documentation practices is a plus.

Responsibilities

• Assist in the development of products from concept to production.
• Develop product requirements according to customer and business needs in compliance with international standards and regulations.
• Adhere to established design control processes and good engineering practices.
• Design and model components and devices using SolidWorks.
• Evaluate parts, products, or processes for efficiency and reliability.
• Provide technical support on components, material methods, systems and equipment.
• Develop risk documentation and test procedures; write and review protocols and data.
• Conduct testing and validation studies on products; perform failure investigations.

Skills

Plastic materials knowledge

Design for manufacturability

DOE & statistics

Project leadership

Materials testing

Cross-functional collaboration

Detail oriented

Communication

Education

Bachelor of Science in Mechanical Engineering

Master's Degree (preferred)

Tools

SolidWorks

Job description

Position Summary

The Product Design Engineer will support the Business Development R&D department. The e ngineer is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices. The key responsibility of this position is to design, develop, and improve ICU’s product portfolio to ensure their efficiency and reliability. The incumbent will be heavily involved with plastics, polymers, molding, medical disposables, plastics engineering, and solid modeling. The R&D Product Engineer will be expected to interface mainly with internal customers and external suppliers on the design and configuration of high-volume disposable medical devices. The position plays a key role in assisting in the development and compliance challenges involved with new medical devices. The position requires the ability to interact with multiple functional groups such as Marketing, Regulatory, Quality, Operations, etc.

• Assist in the development of products from concept to production
• Develop product requirements according to customer and business needs in compliance with international standards and regulations applicable.
• Adhere to established design control processes and good engineering practices
• Design and model components and devices for various product lines using SolidWorks
• Evaluate parts, products, or processes for efficiency and reliability to ensure long-term success of new / improved product lines
• Provides technical support on components, material methods, systems and equipment
• Provides the technical foundation for the development of risk documentation
• Develops test procedures to ensure specifications and regulations are met
• Writes, reviews, and approves protocols, reports and data
• Conducts testing outlined in protocols and test methods
• Executes engineering and validation studies on products
• Conducts failure investigations
• Work on special projects as assigned

Job Description

The Product Design Engineer will support the Business Development R&D department. The e ngineer is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices. The key responsibility of this position is to design, develop, and improve ICU’s product portfolio to ensure their efficiency and reliability. The incumbent will be heavily involved with plastics, polymers, molding, medical disposables, plastics engineering, and solid modeling. The R&D Product Engineer will be expected to interface mainly with internal customers and external suppliers on the design and configuration of high-volume disposable medical devices. The position plays a key role in assisting in the development and compliance challenges involved with new medical devices. The position requires the ability to interact with multiple functional groups such as Marketing, Regulatory, Quality, Operations, etc.

Essential Duties & Responsibilities

• Assist in the development of products from concept to production
• Develop product requirements according to customer and business needs in compliance with international standards and regulations applicable.
• Adhere to established design control processes and good engineering practices
• Design and model components and devices for various product lines using SolidWorks
• Evaluate parts, products, or processes for efficiency and reliability to ensure long-term success of new / improved product lines
• Provides technical support on components, material methods, systems and equipment
• Provides the technical foundation for the development of risk documentation
• Develops test procedures to ensure specifications and regulations are met
• Writes, reviews, and approves protocols, reports and data
• Conducts testing outlined in protocols and test methods
• Executes engineering and validation studies on products
• Conducts failure investigations
• Work on special projects as assigned

Knowledge & Skills

• Detail oriented and ability to organize large amounts of work and data.
• Strong interpersonal skills required in the areas of verbal and written communications, customer focus, time management, professionalism, coaching, influencing, and team building.
• Knowledge of medical device manufacturing practices
• Knowledge of medical grade plastics and general injection molding principles
• Strong knowledge in joining methods of plastics
• Experience with design of experiments (DOE) and basic statistical methods
• Excellent project leadership and ability to expedite project completion
• SolidWorks competency required
• Understanding of engineering mechanics and physics
• Familiarity with machine shop practices
• Familiarity of drafting standards

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• Bachelor of Science degree from an accredited college or university in Mechanical Engineering or a related field. Master's Degree preferred.
• 0-2 years of experience in Medical Device Product Development

Salary Range - $60,000-$80,000

The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.

ICU Medical provides a comprehensive total rewards package that includes:

• Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
• A wide range of benefit options at affordable rates
• Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement

Additional information on health and welfare benefit offerings can be found at Careers: Investing in Your Future | ICU Medical .

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 being an 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, 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 [e-mail]. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

ICU Medical CCPA Notice to Job Applicants