Senior Manufacturing Engineer
Role Title: Senior Manufacturing Engineer
Client: Depuy Synthes
Location: Warsaw, IN
Mode: HCL Full Time
Salary: on W2 + Benefits + Relocation Assistance
Work Authorization: Any VISA
Job Description:
- Experience in virtual team management and onsite / offshore coordination
- Site specific data collection across all relevant sites (Extract data from ERP systems like SAP, MES-CAMSTAR and JD Edwards)
- Experience in data mining, analysis and formulation
- Experience in medical device manufacturing process, process flow and process mapping, quality system, validation and risk assessment
- Experience in technical documentation / business case / change order - writing, reviewing and routing documentation
- Experience in packaging processes and value chain analysis
- Knowledge in sterility assurance / microbiology, verification / validation, assessment of risk and mitigation plans
- Knowledge in product life cycle management, NPI / NPD, and cGxP
- Knowledge in EU-MDR, FDA CFR Title 21, ISO 13485:2016 and understanding of regulatory requirements
- Experience in formulating WBS, creation of work packets and structuring the scope at project level
- Excellent communication and stakeholder management
- Excellent team player with leadership skills
- Experience in Microsoft Excel, PowerPoint and Project
- Knowledge of Project Management is value addition to project