Senior Engineer, Mechanical at ICU Medical, Inc. in Lake Forest, Illinois

Job Description:

Job Description



Position Summary


The primary function of the Senior Engineer in the ICU Medical's infusion systems R&D organization is to provide design solutions for various electro-mechanical medical devices. This includes providing solutions to issues where analysis of designs or test data requires an in-depth engineering evaluation of variable factors pertaining to designs, methods, materials or processes. The role is responsible for developing new design concepts and implementing design changes that affect system performance. This role is also responsible for on-market support which may involve CAPAs, end-of-life issues, manufacturing issues and product/process cost reductions. Work is highly independent, and this role may assume a team lead role for the work group.



Essential Duties & Responsibilities


• Completes advanced engineering projects with peer input and guidance from engineering management.

• Analyzes, plans, organizes and completes projects of a very complex nature. Finite Element Analysis (FEA) modeling is a plus.

• Develops CAD models, prototypes and performs testing to demonstrate feasibility of design concepts

• Integrates subsystems and components in total systems design. Develops BOMS, drawings and specifications from customer / product requirements.

• Assess what work supports the product strategy and make insightful recommendations regarding priorities

• Provide mechanical engineering support in developing design Failure Mode Effects Analysis (dFMEA), Design for Assembly (DFA), Design for Manufacturability (DFM) and Design for Testability (DFT).

• Manages activities of lab technicians, performs lab activities, writes test protocols and reports.

• Adheres to design control procedures and provides engineering deliverables for all phases (concept, definition, development, qualification and launch) of medical device development process.

• Identifies any technical issues and schedule risks and defines appropriate contingency plans

• Communicates with technical leads and management on project direction, status updates, technical / program issues.



Knowledge, Skills & Qualifications


• Product development experience in the medical device industry and familiarity with IEC standards is preferred. Medical device or experience in a regulated industry preferred.

• Advanced understanding of best practices in the design of plastic and metal components. Experience in selection of engineering materials, mechanical components and defining critical dimensions & tolerances.

• Solidworks CAD experience preferred with knowledge of Geometric Dimensioning and Tolerancing (GD&T) best practices.

• Proficient in the use of analytical tools and methodologies, Design for Assembly, Design for Manufacturability, Design for Testability and Tolerance Stack Analysis.

• Familiarity with Risk Management, Risk Documentation and supporting dFMEAs

• Experience in CAPA investigations, Sustaining Engineering / On-Market product support

• Must have strong technical report writing skills.


Education and Experience


• 10 years of electro-mechanical engineering experience in medical device industry is preferred



Minimum Qualifications


• Bachelor's Degree in Mechanical Engineering

• 7+ years of mechanical engineering design experience



Travel Requirements


• Approximately 10%. May vary based on business needs.

• Must be able to travel globally.



Physical Requirements and Work Environment


• Sedentary role in a professional office environment.

• On-site attendance 2-3 days per week

• Some duties are performed in a lab environment.

• Must have the dexterity to build and service electro-mechanical devices



About Us



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 Apply Now