Senior Engineer, Product Design

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

Job summary

ICU Medical Inc. is seeking a Senior R&D Engineer to support Research and Development and Strategic Business Development activities. You will research, develop, and implement novel product concepts with strict design controls and documentation practices.

You will lead product design, development, and improvement across lines to ensure commercial viability, efficiency, and clinical reliability, working with clinicians, customers, and suppliers on complex topics.

Qualifications

• Must be at least 18 years old.
• 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.

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 understand core business needs and drive actionable project level tasks to address those needs.
• Provide in-depth analysis to translate industry-related research into usable and marketable products and support actionable strategies for long-term product visions.
• Evaluate parts, products, or processes for efficiency and reliability to ensure long-term success of new / improved product lines.
• Write and review design control and risk management documents according to Company standards.
• Incorporate medical device standards (FDA, ISO, IEC, EN) into design and development.
• Provide solutions and guidance for technical issues and small projects as they arise.
• Knowledge of medical device design controls and phase gate product development process.
• Knowledge of medical grade plastic manufacturing processes, injection molding design principles, and polymer joining methods.
• Knowledge of SolidWorks for design and modeling of components and devices.

Skills

Strong problem-solving

Interpersonal and project leadership

Analytical thinking

Medical device design controls

Solid modeling

Education

Bachelor of Science in Mechanical Engineering

Tools

SolidWorks

MS Word

MS Excel

MS PowerPoint

MS Project

Job description

Position Summary

The Senior Engineer will support Research and Development and Strategic Business Development activities. The Senior R&D Engineer is responsible for researching, developing and implementing novel product concepts and designs through adherence to established design control processes and good engineering and documentation practices. The key responsibility of this position is the design, development, and improvement of product lines to ensure their commercial viability, efficiency and clinical reliability. The incumbent will be heavily involved with emerging and state of the art plastics engineering, polymers, molding, medical disposables, and solid modeling. The Senior R&D Engineer will be expected to interface directly with clinicians, customers, academic and commercial research groups, and suppliers on complex technical and scientific topics.

Job Description

Position Summary

The Senior Engineer will support Research and Development and Strategic Business Development activities. The Senior R&D Engineer is responsible for researching, developing and implementing novel product concepts and designs through adherence to established design control processes and good engineering and documentation practices. The key responsibility of this position is the design, development, and improvement of product lines to ensure their commercial viability, efficiency and clinical reliability. The incumbent will be heavily involved with emerging and state of the art plastics engineering, polymers, molding, medical disposables, and solid modeling. The Senior R&D Engineer will be expected to interface directly with clinicians, customers, academic and commercial research groups, and suppliers on complex technical and scientific topics.

A Senior Engineer is an individual contributor with responsibility in a professional discipline or specialty. The majority of time involves delivering and overseeing projects, while adhering to policies, from design to implementation using specialized knowledge and skills acquired through advanced education or technical experience.

Independently approaches and resolves technical solutions related to project or product needs. May receive technical guidance on more unusual or complex problems. Works on a diverse scope of problems not of a routine nature and is responsible for selecting methods and techniques for obtaining solutions. Work product typically results in the development of new or refined equipment, materials, processes, products, and/or methods.

Essential Duties & 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 understand core business needs and drive actionable project level tasks to address those needs.
• Provide in-depth analysis to translate industry-related research into usable and marketable products and support actionable strategies for long-term product visions.
• Evaluate parts, products, or processes for efficiency and reliability to ensure long-term success of new / improved product lines
• Write and review design control and risk management documents according to Company standards
• Effectively and thoughtfully incorporate required medical device standards (FDA, ISO, IEC, EN)
• Provide solutions and guidance for technical issues and small projects as they arise
• Knowledge of medical device design controls and phase gate product development process.
• Knowledge of medical grade plastic manufacturing processes, injection molding design principles, and common polymer joining methods.
• Knowledge of design and modeling of components and devices for various product lines using SolidWorks
• Knowledge of various clinical environments including Hospital and Outpatient settings.
• Experience with design of experiments (DOE) and basic statistical methods
• Excellent interpersonal and project leadership skills with 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

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
• Minimum 6 years of experience in Medical Device Product Development and/or Manufacturing Support Engineering

Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel less than 5% of the time

Salary Range - $105,000 - $150,500

The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] 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 https://www.icumed.com/about-us/careers/investing-in-your-future/ .

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