ICU Medical Inc.

Senior Engineer, Product

ICU Medical Inc. • $100K — $130K *
Salt Lake City, UT 84118In-Person
Manufacturing & Automotive
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or Technology from an accredited college or university
  • 7+ years of relevant experience
  • Expertise in materials strength, automation, and plastic injection molding
  • Advanced understanding of risk management and Six-Sigma methodology
  • Familiarity with medical device industry and FDA QSR regulations
  • Proficiency in SolidWorks for part design and simulations
  • Strong capability in project management and team leadership.

Responsibilities

  • Drive product improvements and manage advanced engineering projects
  • Analyze and develop creative solutions for complex project scopes
  • Lead design assessments and ensure adherence to risk management processes
  • Own CAPA tasks to ensure compliance and product efficacy
  • Coordinate with vendors for materials specifications and assessments
  • Identify product modifications to enhance manufacturability
  • Communicate effectively with stakeholders to promote cross-functional collaboration and consensus.

Benefits

  • Professional development opportunities including training and mentoring
  • Collaborative and innovative work environment
  • Engagement in high-impact projects with team leadership potential
  • Exposure to advanced engineering practices and technologies
  • Opportunity to network with senior professionals in the field.
Full Job Description
Job Description

Position Summary

The Sr. Engineer, Product is responsible for owning and driving product improvements through adherence to established design control processes, good engineering and documentation practices. They are considered a specialist on complex technical and business matters, may assume a team lead role for work in the group and be highly independent in accomplishing work. The key responsibility of this position is to completes advanced engineering projects with peer input and guidance from engineering management, exercising judgement and taking action while adhering to defined procedures during project support & improvements.

Essential Duties & Responsibilities
  • Immediate expectations
    • Receives general project direction. Responsible for project progress.
    • Analyze, plan, organize and complete projects of a very complex nature. Develops scope and provide creative solutions. Plans, organizes and conduct technical projects. Consolidates results of design elements of major projects for purpose of design review. Integrates subsystems and components in total systems design. Develops specifications from customer requirements.
    • Initiate and manage projects with adherence to program management guidelines
    • Perform Design assessments, active participation in Design reviews, Risk Management processes.
    • Own and manage CAPA tasks and deliverables (Corrective and Preventive)
    • Coordinate efforts with the Materials Group to assess vendors and provide materials technical information
    • Represent Product Engineering to identify possible product modifications to improve manufacturability and impact on automation equipment
    • Maintain Product specifications; consult with manufacturing on product non-conformance.
  • Work on special projects as they arise
  • Decisions consistently affect multiple or critical projects in the business and may impact external relationships.
  • Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration. Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus
  • Long term expectations
    • Spearhead initiatives for continuous process and product improvements (assess tolerance stack up of sustaining designs to increase robustness)
    • Develop a broad understanding from start to end of the product manufacturing process in the company
    • Network with senior internal and external personnel
    • Intellectual Property review and assessment
    • Manages training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures. May routinely monitor or supervise the work of one or more employees. Provides input on performance evaluations to area manager.

Knowledge & Skills
  • Understanding of strength of materials, automation, plastic injection molding, part assembly, fixturing, testing, and process control techniques
  • Solid works to interpret part dimensions, sectional views, conduct mates & build assemblies. Able to run basic simulations.
  • Risk Management, FMEA generation and Risk Analysis
  • 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
  • Has mastered best practices. Has an advanced understanding of engineering discipline
  • Can assess what work supports the product strategy and make insightful recommendations regarding priorities
  • Expert in your domain of expertise. Familiar in other areas of domain expertise within the team.

Minimum Qualifications, Education & Experience
  • Must be at least 18 years of age
  • Bachelor's degree from an accredited college or university (Engineering or Technology)
  • 7+ years' experience

Work Environment
  • This is largely a sedentary role.
  • This job operates in a professional office environment and routinely uses standard office equipment.
  • Work may be performed in a clean room environment
  • While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating
  • Must be able to occasionally move and lift objects of up to 25 lbs
  • Typically requires travel less than 5% of the time


About ICU Medical Inc.

ICU Medical, Inc. is a global medical device company that develops, manufactures, and sells innovative medical products used in vascular therapy, oncology, and critical care applications. The company's products are designed to improve patient outcomes by helping prevent bloodstream infections and protecting healthcare workers and patients from exposure to infectious diseases or hazardous drugs. ICU Medical's product portfolio includes needlefree connectors, closed system transfer devices, and other medical devices and accessories. The company has operations in North America, Europe, and Asia and employs over 5,100 people worldwide.
Learn more about ICU Medical Inc.
Size
8,500 employees
Market Cap
$3.7 billion
Industry
Healthcare
Net Income
$86.8 million
Founded
1984
5 Year Trend
+28.3%
Revenue
$1.2 billion
NASDAQ
ICUI
* Ladders Estimates

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