Lead Mechanical Engineer

2 weeks ago


Lake Forest, Illinois, United States ICU Medical Full time

Position Overview:
The Senior Mechanical Engineer at ICU Medical plays a pivotal role within the Research and Development team, focusing on the innovation of infusion systems. This position is dedicated to delivering engineering solutions for a variety of electro-mechanical medical devices.

Key Responsibilities:
- Execute complex engineering projects with collaborative input and oversight from management.
- Conduct thorough analyses, planning, and organization to complete intricate projects. Experience with Finite Element Analysis (FEA) is advantageous.
- Create CAD models, develop prototypes, and conduct testing to validate design concepts.
- Integrate various subsystems and components into cohesive system designs. Generate Bills of Materials (BOMs), technical drawings, and specifications based on product requirements.
- Evaluate project work in alignment with product strategy and provide insightful recommendations on priorities.

- Offer mechanical engineering expertise in developing design Failure Mode Effects Analysis (dFMEA), Design for Assembly (DFA), Design for Manufacturability (DFM), and Design for Testability (DFT).
- Supervise lab technicians, manage laboratory activities, and prepare test protocols and reports.

Compliance and Communication:
- Adhere to design control protocols and deliver engineering outputs for all stages of the medical device development lifecycle, including concept, definition, development, qualification, and launch.
- Identify technical challenges and schedule risks, proposing suitable contingency strategies.
- Maintain communication with technical leads and management regarding project direction, status updates, and technical issues.

Qualifications:
- Experience in product development within the medical device sector and familiarity with IEC standards is preferred.
- Advanced knowledge of best practices in designing plastic and metal components, along with experience in selecting engineering materials and defining critical dimensions and tolerances.
- Proficiency in Solidworks CAD and understanding of Geometric Dimensioning and Tolerancing (GD&T) best practices is preferred.

- Skilled in utilizing analytical tools and methodologies, including Design for Assembly, Design for Manufacturability, Design for Testability, and Tolerance Stack Analysis.
- Familiarity with Risk Management and supporting dFMEAs is beneficial.
- Experience in CAPA investigations and on-market product support is desirable.
- Strong technical report writing capabilities are essential.

Education and Experience:
- A Bachelor's Degree in Mechanical Engineering is required.
- A minimum of 7 years of mechanical engineering design experience is necessary, with a preference for 10 years in the medical device industry.

Travel Requirements:
- Willingness to travel globally, approximately 10%, depending on business needs.

Work Environment:
- This role is primarily sedentary within a professional office setting, with on-site attendance required 2-3 days per week. Some responsibilities will take place in a laboratory environment, necessitating the dexterity to assemble and service electro-mechanical devices.

ICU Medical is committed to fostering a diverse and inclusive workplace. 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.



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