Mechanical Engineer - III (Medical Device & Pharma)
We are looking for Mechanical Engineer - III (Medical Device & Pharma) for our client in Warsaw, IN
Job Title: Mechanical Engineer - III (Medical Device & Pharma)
Job Location: Warsaw, IN
Job Type: Contract ? 12 Months / Contract to Hire / Direct Hire
?US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time.?
- This Manufacturing Engineer will support process development of a new product at an existing forging vendor for DePuy Synthes.
- The ME will be responsible for product drawing reviews, process and inspection development, and process validation and verifications of forging for Medical Devices.
- The ME will partner and collaborate with Supplier Quality and Procurement to complete product launch, resolve technical issues that affect Quality or Delivery of product and reduce cost of manufacturing.
The ME is responsible for the following:
- Support supplier process development ? forging and machining
- Assess supplier cost of manufacturing to ideal state and identify opportunities
- Review product drawings (Strong understanding of GD&T including application of surface profiles that are not locked to datums)
- Direct and support PFMEA for supplier process and lead risk assessment effort for overall process
- Develop tasks and timelines to be executed as part of supplier launch
- Develop strategic collaborations across functions, business units and geographic boundaries to achieve effective outcomes over the long-term
- Provide timely and accurate reporting on project activities
- Evaluate and implement processes and programs to improve product quality, reduce cost at supplier
- Review and approve design or process changes from a manufacturing and process engineering perspective ? ensure design for manufacturing
- Collaborate with supplier Process Engineering to ensure supplier?s key process parameters are capable for qualification, verification, and validation activities
- Route and approve Supplier Non-conformances and Corrective actions as required
- Modify Bill of Materials for supplier?s manufacturing process as needed
- Route and approve Supplier Process documentation as needed, i.e. PFMEA, engineering studies, verification/validation protocols and reports
- Knowledge of titanium forging and machining processes
- Ability to work with crossfunctional team and supplier, operators, and Senior Managers
- Ability to read and understand drawings/part prints is required.
- Ability to write and suggestion improvements using PFMEA approach is required.
- Ability to support Supplier packaging process validations/verifications is required.
- Ability to read and understand technical documents is required.
- Ability to be trained and use important business systems ? i.e. SAP, Agile, ETQ is required.
- Deliver to project milestones
- Experience with ISO13485/ Quality Systems Regulations for the Medical Device Industry (FDA QSR)
- Strong problem solving Skills
- Basic LeanEngineering knowledge
- Valid Driver?s License