JOB OPENING(S)
 

Validation Engineer (Pompton Plains, NJ)  - posted on 2/22/23

• Coordinate with cross functional activities with development, validation, qualification, quality, maintenance & compliance to troubleshoot & resolve manufacturing issues

• Identify bottlenecks as well as develop & implement corrective & preventive action plans; & support automation & control system integration

• Travel to various unanticipated client sites.

• Req’s Master’s deg. (foreign equi. deg.) in Mechanical Engineering or related with knowledge of at least 7 of the following skills: IQ, OQ, PQ, cGMP, FAT, Facility & Utility Qualification, Equipment Installation / Commission / Validation, Engineering Assessment, Report for Non-Conformance, Troubleshooting for Production Operations.

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Mechanical Engineer (Pompton Plains, NJ)  - posted on 5/1/23

• Responsible for quality medical device design deliverables to manufacturing meeting DFMA standards and FDA requirements

• Produce assemblies, models and manufacturing drawings using NX CAD; Team center Product Life Cycle Management and data management using SAP. Ability to modify existing design for cost reduction and to resolve malfunction. Use of Finite Element Analysis ANSYS tool for analysis to verify robustness and design intent. Able to utilize statistical tools for data analysis.

• Travel to various unanticipated client sites.

• Req’s Master’s degree (or foreign equi. degree) in Mechanical Engineering or related with knowledge of at least 7 of the following skills: Medical device design, GD&T, Tolerance stack-up analysis, DFMA, FMEA, Product Life cycle Management, Finite Element Analysis, Design of Experiments (DOE), NX CAD, Teamcenter, SAP, ANSYS, Minitab.