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Principal Engineer, Mechanical
4 months ago
Description
Position Summary
The primary function of the Principal Engineer in the Infusion Systems R&D organization is to provide technical leadership and design solutions for electro-mechanical medical devices. This includes providing solutions to complex 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 technical lead is responsible for developing new design concepts and implementing design changes that affect system performance. The technical lead is also responsible for on-market support which may involve CAPAs, end-of-life issues, manufacturing issues and product/process cost reductions.
Essential Duties & Responsibilities
•Applies engineering and scientific principles to generate new concepts and demonstrate proof of principle via analysis and prototypes to align with business unit goals. Develop CAD models, prototypes and perform demonstrations for feedback from key stakeholders.
•Adhere to design control procedures and provide engineering deliverables for all phases (concept, definition, development, qualification and launch) of medical device development process.
•Apply analytical and statistical methodologies to assess design feasibility and to support design decisions. Proficiency in utilizing tools such as Monte Carlo simulations, MatLab, MathCAD and ANSYS Finite Element Analysis (FEA) is preferred.
•Strong design and technical background in selection of engineering materials, plastic and metal components design, geometric dimensioning and tolerance analysis (GD&T), critical to function (CTF), critical dimensions and tolerance stack-up analysis.
•Proficient in design Failure Mode Effects Analysis (dFMEA), Design for Assembly (DFA), Design for Manufacturability (DFM) and Design for Testability (DFT).
•Serve as Subject Matter Expert and provide on-market support as required.
•Responsible for managing and overseeing work conducted by suppliers for testing, engineering analysis and/or product development.
•Identify any technical issues and schedule risks and define appropriate contingency plans
•Effectively communicate to management with status updates, technical issues or any issues related to the project scope, resources and schedule.
•Perform lab, testing or other related duties as assigned.
Knowledge & Skills
•Product development experience in the medical device industry and familiarity with IEC standards is preferred.
•Must be proficient in CAD design of plastic and metal components, selection of engineering materials / components, CAD detailing, defining critical dimensions/tolerances and Geometric Dimensioning and Tolerancing (GD&T).
•Must be 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 developing dFMEAs
•Experience in CAPAs, Sustaining Engineering / On-Market product support
•Must have strong technical report writing skills.
Minimum Qualifications, Education & Experience
•Must be at least 18 years of age
•Bachelor's degree from an accredited college or university is required, preferably in mechanical engineering
•10+ years of mechanical engineering design experience required, preferably in medical device industry
Work Environment
•This is largely a sedentary role.
•This job operates in a professional office environment and routinely uses standard office equipment.
•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
Typically requires travel 5-20% of the time, including globally.
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.
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