Mechanical Inspector

Position Summary

This position is responsible for performing tasks directly related quality assurance and control. This role involves performing visual and dimensional measurements of molded components, sub-assemblies, and final product. Measurements also include functional testing and assessment of physical attributes in some cases. The Mechanical Inspector will also create measurement inspection plans and programs for molded components and participate in validation testing using optical and contact measuring machines. This position is responsible to ensure that medical devices and components are measured/inspected with the highest quality possible. Provide support for NCMRs, investigations, and other duties as needed. The ideal candidate will possess strong attention to detail, technical expertise in metrology, and a commitment to maintaining high-quality standards in a fast-paced manufacturing environment.

Essential Duties & Responsibilities

• Read, interpret, and understand drawings and specifications
• Use hand gauges for inspections (calipers, micrometers, height/depth gauges, etc.)
• Use measurement machines such as OGP SmartScope, Zeiss O-Inspect, and similar machines for optical and contact measurement via a computer interface
• Product sampling and subsequent part inspection according to specifications
• Report and generate material non-conformance lot reports (NCMR's)
• Recognize and communicate deviations from accepted practices in all areas of quality review
• Follow cGMP
• Create robust inspection plans and/or routines
• Perform First Article and Validation Inspections
• Perform Gauge R&R when needed
• Using SPC software analyze statistical data
• Work on special projects as they arise

Knowledge, Skills & Qualifications

• Strong knowledge of Plastic Processing
• cGMP knowledge
• Basic math skills
• Basic computer knowledge
• Strong written and verbal communication skills
• Familiarity with ASTM Standards a plus
• Familiarity with ISO 9001, 13485 and Medical Manufacturing Environments a plus
• Must be detail oriented and follow instructions and specification meticulously
• Knowledge of SPC software, preferably Prolink QC-Calc
• Ability to program smart scope software, preferably QVI Zone 3, Measuremind3D and Zeiss Calypso
• Understanding of measurement theory and practices including geometric dimensioning and tolerancing (GD&T) per ASME Y14.5

Education and Experience

• High School diploma or equivalent
• Minimum 2 years of experience performing measurement inspections in manufacturing environment

Preferred Qualifications

• 2+ years of experience creating automated routines with Measuremind, Zone 3, Calypso, or similar software
• 4+ years of experience performing measurement inspections in an FDA regulated manufacturing environment, preferably medical device components

Minimum Qualifications

• Must be at least 18 years of age

Travel Requirements

• Typically requires travel less than 5% of the time

Physical Requirements and Work Environment

• Work is generally 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
• Operator is required to use computer, touch screen, or pen and paper to enter data
• Must be able to occasionally move and lift objects of up to 25 lbs

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