| Product Development Engineer at Remote, Remote, USA |
| Email: [email protected] |
| From: Khayal Abbas, Scalable- Systems [email protected] Reply to: [email protected] Job Title Product Development Engineer Rate $40/hr Technical/Functional Skills Understanding of Engineering principles, Product designs, Product Lifecycle, Design Specifications, Product Requirements and Product mechanisms Understanding of Medical Devices and related Regulatory Standards Understanding and experience of Design, Development, Verification and Validation activities and creating related documents for medical devices Engineering documentation for new product development and sustenance engineering activities for medical devices Concept Design for medical devices/ Instruments 3D CAD modeling and drafting in NX and Solid works Engineering drawing interpretation including GD&T fundamentals Understanding of product requirements management framework Understanding of Manufacturing processes and its limitations & Assembly processes related design constraint Fair understanding of material usage as applicable for medical devices Manufacturing and process development experience Experience with assembly techniques and equipment technologies Process validation (GMP) Statistical process control / capability analysis Measurement system analysis, including GR&R Risk analysis, including use of FMEA Experience Required 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) Good knowledge in design program/project approach and governance Knowledge of change management and communication plans Preferred experience with design, engineering and functioning of surgical devices Experience in CAD tools (like Unigraphics NX and Solidworks), Component and Assembly Drawings, Engineering Analysis Reports, Experience in GD&T and Tolerance Analysis Experience in Design verification and Validation Knowledge of statistical analysis and its applicability to derive engineering rationale 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 Work Location (State, City and Zip) Blue Ash, Ohio Keywords: rlang |
| [email protected] View all |
| Sat Dec 09 01:46:00 UTC 2023 |