Engineer 1
Engineer I
Contract: 12 months
Location: Round lake, IL – Onsite
Essential Duties and Responsibilities:
· Responsible for developing and executing verification and validation protocols related to Renal therapy.
· Experience in translating product requirements into test / use cases, essential.
· Responsible for design and development of precision plastic devices and components, developing test plans for functional testing, biocompatibility testing of materials and qualification of sterile packaging.
· Perform standard engineering assignments which are typically a significant portion of a larger project.
· Select sound techniques to solve problems and make design recommendations under direction of supervisor. Assess results for application, validity and conformance to specifications.
· Revise/Create product and process specifications, product labeling, Bills of material
· Utilize engineering tools to solve problem (e.g., Risk Management, FMEA, Finite Element Analysis, Process Modeling, Design of Experiments, 3D modeling and rapid prototyping, perform data analytics, Tableau, DMAIC, and SPC).
· Monitor and report project costs including capital and cross-functional expenses. Estimate cost affected by design and/or policy changes. With supervisor, recommend capital expenditure and production methods for existing or enhanced products or processes.
· Design Studies to evaluate and recommend techniques to improve existing products/processes.
· Perform testing, develop test methods, procure products and materials, and test method validation
Requirements
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.
· Experience with Six Sigma and DMAIC tools desired
· Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools, MiniTab, Excel, Tableau)
· Experience in Technical writing, statistical analysis, cross functional communication, experimental design, and verification and validation of requirements and user needs.
· Knowledge should include experience with device Design History File structure, Risk Management documentation and Product Requirements management, and Test Method Validation, Product change control execution, and complaint handling
· Understand and articulate how own role ties within function or discipline.
· Capable of communicating and driving cross-functional activities globally
· Demonstration application of engineering principles on individual/small projects
Education and Experience:
· 1 - 3 years Medical Device experience or internships with an emphasis on plastic disposables
· Background and/or Experience: BS engineering and 1-3 years related experience.