Engineer III, Product

Posted 14 Days Ago
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Salt Lake City, UT, USA
In-Office
Mid level
Healthtech • Software
The Role
Supports sustaining engineering and continuous improvement for medical device products and manufacturing systems. Responsibilities include improving yield, cycle time, quality, and manufacturability; managing CAPA activities, component obsolescence, testing, design specifications, and engineering projects; analyzing processes and developing solutions; coordinating with materials and vendors; and supporting documentation, training, and cross-functional communication.
Summary Generated by Built In

Position Summary 

The Product Sustaining Engineer III is responsible for supporting product improvements through adherence to established design control processes, good engineering and documentation practices. The key responsibility of this position is to exercise judgement and take action while adhering to defined procedures during project support & improvements.  

The Product Sustaining Engineering III will complete advanced engineering projects with input and guidance from senior engineers and managers. Gains exposure to some of the complex tasks within the job function. 

Essential Duties & Responsibilities

  • Support initiatives for continuous process and product improvements
  • Work to improve performance of manufacturing systems, e.g. yield, cycle-time, quality requirements, maintenance’s needs
  • Support project timelines and milestones and bring them to completion on time and within budget
  • Assist in completion of CAPA tasks and deliverables (Corrective and Preventive)
  • Identify and qualify “end-of-life” components.
  • Represent Sustaining Engineering to identify possible product modifications to improve manufacturability and impact on production processes.
  • Initiate and manage projects with adherence to program management guidelines
  • Coordinate efforts with the Materials Group to assess vendors and provide materials technical information
  • Conducts independent analysis and develops solutions to problems.
  • Develops approaches and designs where precedent usually exists.
  • Performs developmental and/or test work that relies heavily on a comprehensive knowledge of theory and design.  
  • Writes detailed design specifications.
  • Assists in training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
  • Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
  • Work on special projects as they arise

Knowledge, Skills & Qualifications

  • Understanding of strength of materials, automation, plastic injection molding, part assembly, fixturing, testing, and process control techniques
  • Knowledge of Solidworks to interpret part dimensions, sectional views, conduct mates, build assemblies.
  • Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) - use of Minitab Software for analysis
  • Knowledge of the Medical Device Industry and familiarity with FDA QSR Regulations is a plus
  • Competent in your domain.  Familiar with other areas of domain expertise within the team.
  • Has a basic understanding of best practices. Has a basic to intermediate understanding of engineering discipline
  • Have awareness of the broader product strategy and contribute to it
  • Ability to receive general project direction and solicit input from more experienced engineers.
  • Requires the ability to independently make decisions that impact the attainment of project 

Minimum Qualifications

  • Must be at least 18 years of age

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. 
  • 4+ years of experience in Medical Device Product Development or related field

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
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 [email protected]. 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

Skills Required

  • At least 18 years of age
  • Bachelor of Science degree in Mechanical Engineering or a related field from an accredited college or university
  • 4+ years of experience in medical device product development or a related field
  • Knowledge of strength of materials, automation, plastic injection molding, part assembly, fixturing, testing, and process control techniques
  • Knowledge of SolidWorks for interpreting dimensions, sectional views, mates, and assemblies
  • Knowledge of Six Sigma methodology, including DOE, process capability, and Gage R&R, with Minitab analysis experience
  • Master's degree
  • Knowledge of the medical device industry and familiarity with FDA QSR regulations

ICU Medical Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICU Medical and has not been reviewed or approved by ICU Medical.

  • Retirement Support — Retirement offerings include a 401(k) with a company match and mentions of immediate vesting in some cases. Feedback suggests this component is one of the more reliable strengths of the package.
  • Leave & Time Off Breadth — Paid time off and holidays are consistently highlighted as stronger elements within the benefits mix. Feedback suggests time-off policies compare favorably relative to other benefit areas.
  • Healthcare Strength — Core coverage spans medical, dental, and vision alongside HSA/FSA and life/disability options. Feedback suggests the breadth is comprehensive even if the depth feels average in places.

ICU Medical Insights

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The Company
HQ: San Clemente, CA
7,794 Employees

What We Do

ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables. Since IV therapy is our only business, meeting your IV needs with quality products and consistent supply is our only concern. We are 100% focused on bringing you intuitive, patient-centric IV products and services that provide meaningful clinical differentiation, consistent innovation, and superior value. We design our products to work within your existing workflows to minimize disruption and maximize the time you spend with patients. Together, we help forge the human and emotional connections that enhance clinical experience and are the essence of outstanding quality of care. For more than three decades, we have been dedicated to a singular purpose—improving the safety and efficiency of IV therapy. With the acquisition of Hospira Infusion Systems from Pfizer in 2017, we became the only company to focus exclusively on IV therapy across the continuum of care. 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.

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