| Equipment Development Engineer at Remote, Remote, USA |
| Email: khadar@kksoftwareassociates.com |
|
From: Khadar, KK Associates LLC khadar@kksoftwareassociates.com Reply to: khadar@kksoftwareassociates.com We are hiring Equipment Development Engineer Consultants for one of my client in Location:- Cincinnati, OH interesting candidates please send resumes to khadar@kksoftwareassociates.com Contact:- 6146995972 -105 Position:- :- Equipment Development Engineer Location: - Cincinnati, OH JD:- Equipment Development, Component Qualification, Tool Design, Process Qualification, Engineering Build Equipment Development Engineer Lead equipment development projects. Prepare equipment development project proposals. Conduct equipment development concept verification. Perform SOW & risk analysis and mitigation. Evaluate equipment suppliers. Oversee equipment design, design review, and verification. Follow up on equipment manufacture and delivery. Conduct equipment acceptance tests (FAT/SAT). Create equipment operation manuals, specifications, and technical drawings. Oversee equipment installation and debugging. Perform equipment operational tuning and improvements. Verify equipment functionality and reliability. Develop equipment operation and maintenance work instructions. Validate equipment (validation protocol, execution, and report). Provide training on equipment operation to maintenance and production teams. Manage equipment changes and upgrades. Handle other assignments as assigned by a superior Must have experience in the medical devices industry as well as a basic understanding of the regulatory requirements Must have experience in Engineering Documentation for medical devices (Product Design & Development Documents, Protocols, Test Reports, MEMOs and Rationales for Engineering Activities) Hands on prototyping, debugging, knowledge of inventory management. Experience on equipment/ tool development and qualification Good knowledge in design program/project approach and governance Experience in Design verification and Validation Knowledge of statistical analysis and its applicability to derive engineering rationale Knowledge of change management plans Preferred experience with design, engineering and functioning of surgical devices Development & Conduct of Engineering /Test Studies Experience in Process Qualification (IQ/OQ/PQ) and Factory Acceptance Testing Knowledge of Design of Experiments or Process Characterization Experience in different manufacturing and assembly process, DFMA principles Experience in custom fixture/gauge design/Fail proof principles Exposure to trouble shooting and root cause analysis KK Associates LLC. 8751 Collin McKinney Pkwy, # 1302, McKinney, TX 75070 555 Metro Place North, Suite # 100, Dublin, OH 43017 Direct: +1 614-699-5972 | Fax: (614) 413-3428 Email: khadar@kksoftwareassociates.com Keywords: Ohio Texas Equipment Development Engineer khadar@kksoftwareassociates.com https://jobs.nvoids.com/job_details.jsp?id=2131184 |
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| 01:11 AM 31-Jan-25 |