Senior Engineer, Mechanical
Lake Forest, Illinois
Employer: ICU Medical
Industry:
Salary: Competitive
Job type: Full-Time
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
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration 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.
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 consideration 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.
Created: 2024-09-28
Reference: 24300826
Country: United States
State: Illinois
City: Lake Forest
Similar jobs:
-
Mechanical Design Engineer Intern
Precision Quincy in South Beloit, Illinois -
Senior Mechanical Design Engineer
System One Holdings, LLC in Naperville, Illinois -
Senior Mechanical Project Engineer
The Richmond Group in Chicago, Illinois -
Assistant Mechanical Engineer - Power (Chicago)
Burns & McDonnell in Chicago, Illinois -
Mechanical Engineer
Insight Global in Peoria, Illinois -
Assistant Mechanical Engineer - 1898 & Co. Energy & Utilities Consulting (Chicago)
Burns & McDonnell in Chicago, Illinois -
Senior Mechanical Engineer - Aviation & Federal (Chicago)
Burns & McDonnell in Chicago, Illinois -
Sr. Mechanical Engineer
IDEX Corporation in Wheeling, Illinois -
Senior Mechanical Engineer
Volt in East Peoria, Illinois💸 $41.82 - $58.65 per hour -
Mechanical Design Engineer
Koch Industries in Lisle, Illinois -
Senior Engineer, Mechanical
ICU Medical in Lake Forest, Illinois -
Mechanical Design Engineer
Koch Industries in Lisle, Illinois -
Mechanical Engineer - Refrigeration (Multiple Locations)
Burns & McDonnell in Chicago, Illinois -
Mechanical Engineer
Insight Global in Chicago, Illinois -
Entry Level Mechanical Design Engineer
Precision Quincy in South Beloit, Illinois💸 $65000 - $70000 per year -
Lead Mechanical Engineer - Hydropower - Hybrid
Black and Veatch in Chicago, Illinois💸 $108108.00 per year -
Mechanical Engineer
Miner Enterprises Inc. in Geneva, Illinois -
Senior Mechanical Project Engineer-Mission Critical Facilities- Buildings
Stantec in Chicago, Illinois💸 $108000 per year -
Experienced Mechanical Design Engineer
Precision Quincy in South Beloit, Illinois💸 $70000 - $85000 per year -
Mechanical Engineer III
Chicago Transit Authority in Skokie, Illinois