Senior Engineer, Mechanical - 24300826-8088 - ICU Medical, Inc.
Lake Forest, IL
About the Job
This job was posted by https://illinoisjoblink.illinois.gov : For more
information, please see:
https://illinoisjoblink.illinois.gov/jobs/12230617 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
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All
qualified applicants will receive conside ation for employment without
regard to race, color, religion, sex, sexual orientation, gender
identity, national origin, or protected veteran status and will not be
discriminated against on the basis of disability.
information, please see:
https://illinoisjoblink.illinois.gov/jobs/12230617 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
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All
qualified applicants will receive conside ation for employment without
regard to race, color, religion, sex, sexual orientation, gender
identity, national origin, or protected veteran status and will not be
discriminated against on the basis of disability.
Source : ICU Medical, Inc.