Engineer II, Validation & Verification
ICU Medical, Inc.

Job Info

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Job Description

Position Summary

This position is for a Validation Engineer to support the full range of validation project tasks from test design/development, test execution, and reporting.

Essential Duties & Responsibilities

• Reviews user needs for validation test applicability
• Define testing to demonstrate usability and safe use of medical device products using various design validation test methods
• Define sub-plans for validation testing such as: working with vendors and suppliers, preparing statements of work, and preparing test articles and environments
• Report and follow up on issues identified during test development
• Setup and prepare test environments
• Recruit nurses and end users for system validation testing based on practical and clinically relevant use cases / use scenarios
• Moderate end user studies
• Execute validation test protocols
• Collect test data and follow up on issues identified during test execution
• Support validation lead on preparation of plans, test protocols and test reports as part of DHF documentation
• Work on special projects as they arise

Education and Experience

• BS degree in biomed, computer science, EE or related field
• 2-4 years of experience in verification/validation role
• Experience with medical devices and drug administration in a clinically relevant setting (e.g., hospitals, clinics) preferred but not required

Knowledge, Skills & Qualifications

• Required
  • Ability to quickly learn variety of custom software applications
  • Ability to work with engineering staff and other cross-functional team members
  • Experience with Microsoft Office, specifically Word and Excel
• Preferred
  • Experience with product development methodologies including validation of user needs and risk controls by interacting with end users to gather data
  • Experience with medical devices and regulations related to medical devices (FDA/ISO)

Minimum Qualifications

• Must be at least 18 years of age
• Must pass pre-employment drug screen and background check

Travel Requirements

• Typically requires travel less than 5% of the time

Physical Requirements and Work Environment

• This is largely a sedentary role.
• This job is work from home/remote with approximately 10-15% in San Diego office during user study preparation and execution.
• Must be able to occasionally lift objects of up to 25 lbs.

Pay Range: $75,000-107,500

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.

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

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