Engineer I, Product Design

Description

Position Summary

The Product Engineer I - Consumables will be responsible for executing key design development and engineering activities to support new product development and on-market engineering projects for the Consumable IV Set product lines. The Product Engineer I will execute Design Controls, including Requirements Management, Design Outputs, Verification &Validation, Design History File management, and Risk File management. This engineer will author protocols and reports, conduct data analysis, support improvements in Consumables Product Development and Design Controls process and tools, and support regulatory body audits, as needed.

This is an engineering role that is expected to have emerging experience in the development and maintenance of medical device products. The Product Engineer I will be expected to execute on key projects under guidance and mentorship of senior staff and to consistently show progress developing their Medical Device Product Engineering core competencies.

Essential Duties & Responsibilities

• Work with cross-functional teams to ensure products will meet customer expectations while delivering critical IV therapies safely and effectively

• Support the timely and efficient completion of new product launches and design changes

• Build and maintain Design History Files and Risk Management Files for various devices in the Consumable IV Set portfolio

• Develop Design Requirements, Inputs, and Outputs for multiple projects and products.

• Develop Design Verification and Validation Plans, Protocols, and Reports, including statistical data analysis.

• Plan, execute, and document Technical Design Reviews throughout the product development process.

• Support on-market engineering activities

• Support FDA and other regulatory audits of product design history and technical files

• Work on special projects as neede

Knowledge, Skills & Qualifications

• Strong technical writing and communication skills

• Experience with product development, prefer Medical Device Design Controls, and/or Design History Files per 21 CFR Part 820, ISO 13485, and ISO 14971

• Experience with product verification testing and reporting

• Experience with Good Documentation Practices

Education and Experience

• 0-2+ years of experience is required

• Experience in medical device product development is preferred

• Bachelor's degree in engineering or applicable science from an accredited college or university

Minimum Qualifications

• Must be at least 18 years of age

• Must pass pre-employment drug screen and background check

Travel Requirements

• Typically requires travel less than 5% of the time

Physical Requirements and Work Environment

• This is largely a sedentary role.

• This job operates in a professional office environment and routinely uses standard office equipment.

Physical Requirements and Work 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 or touch screen to complete work

• Must be able to occasionally move and lift objects of up to 25 lbs.

We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.

ICU Medical, Inc. encourages individuals with disabilities to apply for positions of interest. If you need accommodations to complete the application process, please contact Human Resources at 949-366-3578.