Engineer III, Quality at ICU Medical, Inc. in Salt Lake City, Utah

Job Description:

Job Description



Position Summary


The Engineer III, Quality - Post Market Quality provides hands-on technical quality engineering support for product complaint investigations across multiple manufacturing facilities. This role ensures investigation findings are appropriately addressed and involves direct interaction with customers and Global Field sales reps. Responsibilities include accomplishing established quality goals, completing intermediate projects with guidance, and supporting post market risk evaluations. This includes authoring, tracking, and ensuring timely closure of post market risk assessments.


Essential Duties & Responsibilities

• Be a product expert on design, manufacturing, failure modes, and field use.
• Authoring and coordination of cross-functional risk analyses for potential post market actions.
• Investigate medical device customer complaints efficiently and accurately.
• Write timely and effective investigation reports.
• Provide quality support and communicate complaint findings with manufacturing sites.
• Liaise with Quality, Engineering, and Operations to understand ongoing CAPA investigations and product issues.
• Contact US customers to address ongoing issues and provide updates on quality initiatives.
• Analyze trend data to identify biases or trends.
• Work effectively in a team environment with shifting priorities.
• Conduct basic standardized tests and submit functional testing requests.
• Work with contaminated medical devices in a controlled setting.
• Perform other functions as necessary or assigned.
• Conduct independent analysis and develop solutions to problems.
• Develop approaches and designs based on existing precedents.
• Perform developmental and test work relying on comprehensive knowledge of theory and design.
• Write detailed design specifications.
• Receive general project direction and solicit input from more experienced engineers.
• Assist in training new/current employees on documentation, equipment use, laboratory techniques, and department procedures.
• Deliver tailored communications to managers, peers, and customers to promote cross-functional collaboration.

Knowledge & Skills

• Experience in team environments bringing medical device products through FDA regulatory pathways and compliance with internal QMS.
• Experience writing requirements and specifications for regulated products, including design traceability and verification and validation plans.
• Excellent technical writing skills.
• Ability to train and transfer knowledge to others.
• Proficient in Microsoft Office and statistical analysis programs.
• Good written and verbal communication skills.
• Strong knowledge of plastic processing and disposable medical device manufacturing.
• Good mechanical aptitude.
• Ability to handle returned contaminated medical devices safely and competently.
• Competent in domain expertise and familiar with other areas within the team.
• Basic understanding of best practices and engineering discipline.
• Awareness of broader product strategy and ability to contribute to it.
• Ability to make independent decisions impacting project objectives.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age.
• Bachelor's degree in Engineering or Technology from an accredited college or university.
• 4-7 years of experience.
• CQE/CRE Certification desirable.
• Prior experience in quality assurance preferred.
• Experience in regulated manufacturing or pharmaceutical/healthcare environments preferred but not required.

Work Environment

• Largely a sedentary role in a professional office environment using standard office equipment.
• Work performed in a safe environment.
• Regularly required to work with contaminated medical devices in a controlled laboratory setting.
• Must occasionally move objects up to 15 lbs.
• Typically requires travel 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