Engineer III, Systems

Company: ICU Medical
Location: San Clemente
Posted on: March 13, 2023

Job Description:

Engineer III, Systems - San Clemente, CA



Responsibilities

Technical focal point role having overall ownership of new product system performance for Invasive Monitoring devices. Ensure product user requirements are clearly defined, testable, traceable, and well

documented per 21 CFR 820. Develop design requirements, concept builds and support transfer to manufacturing plans. Ensure successful completion of system integration and verification and validation testing. Coordinate technical activities on the system between all contributing disciplines including marketing, hardware, software, clinical, regulatory, and quality. Partner with user and marketing to develop a complete understanding of the clinical intended use and its application in the real-world environment. Support development and creation of clinical use cases for testing and human factors studies. Write engineering performance specifications in compliance with company standard operating procedures. Develop basic clinical models and test setups for system integration, troubleshooting and validation. Perform data collection and analysis related to the system performance. Produce test protocols and reports in support of regulatory submissions. Coordinate with all members of the Product Development Team including, project management, quality, regulatory, clinical, manufacturing, purchasing and finance.



EDUCATION AND EXPERIENCE REQUIREMENTS: - - - - - - - - - - -



Bachelor's degree or foreign equivalent in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or closely related field, plus 6 (six) years of experience in Electromechanical medical device development -or equivalent regulated industry, the job offered or a closely related occupation OR a Master's degree in in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or closely related field, plus 4 (four) years of experience in Electromechanical medical device development - or equivalent regulated industry, the job offered or a closely related occupation.



SPECIAL REQUIREMENTS:



Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be "quantified" by "time." Required expertise/knowledge includes: Experience in new product development with successful design from concept to commercialization . Experience in rapid product development, system development and integration, creative design, hands-on prototyping and troubleshooting, process development, design for manufacturing, and project management. Knowledge of FDA Medical Device Design Control processes including, User Needs, Stakeholder Needs, Design Input, - Design Output, Verification & Validation, and Design Transfer. Ability to work closely with Clinical/Medical representatives in support of Risk Management File (RMF) activities including Risk Analysis and Failure Mode and Effect Analysis (FMEA) activities. Knowledge of system identification, modeling, analysis, architecture, integration, and testing as it relates to medical device systems. Ability to work with cross functional teams (e.g. marketing, regulatory, quality) and expedite project completion, and experience in project leadership. Foundation in the development of complex (hardware, software, mechanical) medical devices. Ability to fully support R&D group and Quality department by building quality into all aspects of work and by maintaining compliance to all standard operating procedures (SOP) consistent with FDA 21 CFR part 11 and part 820 regulations. Proven experience in problem solving design, process or customer use issues. Proven experience communicating technical data to technical and nontechnical audiences.





$116,688- $120,750 per year

ICU Medical, Inc. is an equal opportunity employer.

To apply for ICU Medical's Engineer III, Systems position please send resume to: Ana Robles at humanresouces@icumed.com. Must reference JOB CODE: CA0119VG

EOE M/F/D/V

It is the policy of ICU Medical, Inc. to afford full equal employment opportunity to qualified employees and applicants, regardless of their race, color, religion, sex, national origin, age, physical or mental handicaps, military or veteran status, sexual preference, or any other protected condition or characteristic in conformity with all applicable federal, state and local laws and regulations.

Keywords: ICU Medical, San Clemente , Engineer III, Systems, Other , San Clemente, California