ICU Medical Inc.

Engineer II, Design Quality (hybrid)

ICU Medical Inc. • $80K — $95K *
Southington, CT 06489Hybrid
Healthcare
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in engineering (Electrical, Mechanical, Biomedical) or related field
  • Minimum of two years of experience in R&D and/or Quality
  • Knowledge of Quality Management Systems
  • Familiarity with ISO 13485, MDSAP, EU MDR and ISO 14971 standards
  • Statistics knowledge and Minitab proficiency preferred
  • ASQ CQE certification preferred

Responsibilities

  • Utilize quality tools and processes to assure product quality
  • Ensure compliance with FDA regulations and international standards
  • Support the development and maintenance of quality standards
  • Ensure Quality attributes for design changes are met
  • Participate in design reviews and risk assessments
  • Evaluate and mitigate product and process risks for quality improvement
  • Support internal/external audits and maintain Design History Files

Benefits

  • Opportunity to work in a professional office environment
  • Engage with cross-functional teams for diverse experiences
  • Involvement in special projects that enhance skills
  • Limited travel requirements (less than 5-10%)
Full Job Description
Job Description

Position Summary

Provide quality support for ICU Medical Consumable development. The Design Quality Engineer II will support activities such as CAPA investigations, design projects, and will ensure compliance with ICU Medical quality system requirements and applicable regulations and standards, such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards.

Essential Duties & Responsibilities
  • Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
  • Assures conformance with regulations of the FDA and other international regulatory agencies.
  • Supports the development, application, and maintenance of quality standards.
  • Ensure all Quality attributes for design changes are met.
  • Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
  • Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.
  • Support any potential internal and/or external audits and inspections.
  • Maintain Design History Files (DHF) up to date as needed.
  • Effectively interact with cross-functional team members.
  • Provide quality support and for on-market product issues. Bring issues to closure and escalating to management for support as necessary.
  • Work special projects as assigned

Knowledge & Skills
  • Knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
  • Knowledge of medical device standards, ISO 13485, MDSAP, EU MDR and ISO 14971.
  • Knowledge in Statistics (Tolerance limits, Cpk, etc.) and Minitab is preferred.

Minimum Qualifications, Education & Experience
  • Must be at least 18 years of age
  • Bachelor's degree in engineering (Electrical, Mechanical, Biomedical) or related field from an accredited college or university is required.
  • Minimum of two years of experience in R&D and/or Quality is required.
  • ASQ CQE certification preferred

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 5-10% 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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