Senior Engineer, Mechanical
ICU Medical, Inc.

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.