Leader in medical device manufacturing is looking for Engineer in Round Lake, IL for a contract role expected to last 12 months, possible extension, possible temp to perm. The Engineer is 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.
location: Round Lake, Illinois
job type: Contract
salary: $28.00 - 32.45 per hour
work hours: 8am to 5pm
- 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.
- 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.
- BS engineering.
- 1 - 3 years Medical Device experience.
- Experience level: Experienced
- Education: Bachelors
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