Note: The job is a remote job and is open to candidates in USA. Novozen Healthcare LLC is seeking a Manufacturing Engineer to support medical device manufacturing operations. The role focuses on process remediation, new product launch readiness, design transfer deliverables, manufacturing documentation, risk management, configuration management, and cross-functional collaboration with R&D, Quality, and Regulatory teams.
Responsibilities
- Support in Manufacturing process remediation and readiness activities for new product launch
- Support Design Transfer deliverables, including tracking and scheduling
- Support/Initiate Change Order for manufacturing documentation such as but not limited to, manufacturing procedures, shop floor paperwork, and inspection procedures
- Risk Management updates – PFMEA
- Part creation in Windchill. BOM and configuration management
- Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Skills
- 5+ years of Medical device Manufacturing experience
- Applicants must be authorized to work in the United States
- Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control
- Previous medical device experience
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