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New · posted Oct 28

ICU Medical · Medical Devices

Senior Engineer, Quality

  • Highland, IN
  • On-site
  • Full-time
  • Senior & Principal
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PayNot published
EmploymentFull-time
LocationHighland, IN
LevelSenior & Principal
FunctionQuality Assurance
DeadlineOpen until filled

The role

Provide quality support and assurance for ICU Medical product development. The Quality Engineer will be responsible for development procedures and deliverables, ensuring their 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).  The Quality Engineer will provide quality assurance support for product realization/manufacturing teams for the system (includes aspects of electro-mechanical, software and consumable components) product lines.  This individual will be the Quality Core Team Member for ensuring products are developed/manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed.

What you need

Minimum Qualifications, Education & Experience

  • Must be at least 18 years of age
  • Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Software) or related field from an accredited college or university is required.
  • Minimum of 7+ years of experience in quality engineering, product design or product engineering in the medical device industry
  • ASQ CQE or CSQE required or the ability to obtain within one year.

Knowledge & Skills

  • Expert quality compliance, audit, and investigation skills
  • In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
  • Strong knowledge of medical device standards, including but not limited to:
    • ISO 13485
    • ISO 14971
    • IEC 60601
    • IEC 62304
  • In depth experience with and knowledge of FDA, MDR, and other key medical device regulations
  • Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables)
  • Proven ability to work closely with engineering teams and members of a cross functional team
  • New product development experience is strongly preferred.

Skills named in this posting

What you'll do

  • Ensure the safety of products developed by managing the product life cycle activities to meet the quality system requirements.
  • Ensure compliance, alignment and consistency with ICU Medical’s quality system and development practices.
  • 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.
  • Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections.
  • Perform periodic audits of projects against SOP’s and process.
  • Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, code review, and unit test inspections.
  • Review, approve and participate in qualification of acquired software and software tools.
  • Perform and support product risk analysis and management.
  • Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc.
  • Monitor product data to identify statistically significant trends and risks.
  • Support on-market issue investigations, risk assessments and associated CAPA activities.
  • Review and approve resolution of on-market product issues.
  • Support regulatory submissions and responses to regulatory inquires.
  • Work special projects as assigned

Where you'll work

Highland, INOn-siteOpen in Maps (opens in a new tab)

More jobs in Highland, IN

Working conditions

  • This is largely a sedentary role.
  • This job operates in a professional office environment and routinely uses standard office equipment.
  • Typically requires travel 5% to 10% of the time

Job intelligence

The context around this role

Live data · October 28, 2026

Salary intelligence

How the pay compares

Senior & Principal roles in Indiana15 roles publishing pay

Middle half $117,000 to $127,750, median $119,000

Senior & Principal roles in the US323 roles publishing pay

Middle half $104,000 to $142,250, median $122,000
Annual base pay
Annual base payLowMedianHigh
Indiana$117,000$119,000$127,750
All US$104,000$122,000$142,250

Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 28, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Quality Assurance

The general path across 961 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not ICU Medical's own promotion track.

  1. One step back

    Associate & Specialist

    Often: Quality Engineer · Quality Assurance Specialist

    $81K median260 open

  2. This role

    Senior & Principal

    Often: Quality Engineer · Senior Quality Engineer

    $122K median408 open

  3. Next step

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $151K median155 open

  4. Later

    Director

    Often: Director, Quality · Associate Director, Quality Assurance

    $209K median122 open

  5. Later

    VP & Executive

    Often: AVP · DX Head of Regions Quality Management and Regulatory Affairs

    $306K median16 open

Career resources on Quality Assurance

Skills DNA

What this role leans on

How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 7 linesLab testing and methods: 1 lineDocumentation and SOPs: 3 linesInvestigations and CAPA: 5 linesValidation and qualification: 2 linesRegulatory submissions: 2 linesQuality systems and risk: 7 linesData and digital systems: 4 linesCollaboration and leadership: 3 linesGMPLab testingDocumentationInvestigationsValidationSubmissionsQuality systemsData systemsTeamwork
  • GMP and compliance7
  • Quality systems and risk7
  • Investigations and CAPA5
  • Data and digital systems4
  • Documentation and SOPs3
  • Collaboration and leadership3
  • Validation and qualification2
  • Regulatory submissions2
  • Lab testing and methods1

Regulatory intelligence

The rules behind this role

Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

ICU Medical on Regulatory Jobs

8
Open roles
8
Distinct roles
5
Locations

By discipline

  • Quality7 88%
  • Regulatory1 13%

By level

  • Senior & Principal4 50%
  • Associate & Specialist4 50%
See all 8 ICU Medical roles

More roles at ICU Medical

All 8 ICU Medical roles

Similar Quality Assurance roles elsewhere

Senior Engineer, Quality at ICU Medical

Open until filled.

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