bout the role:
The client is looking for a Medical Device Manufacturing Engineer who has strong experience in new product introduction (NPI), Design Transfer, manufacturing documentation, Windchill, BOM/configuration management, and PFMEA.
Manufacturing Engineer with 5+ years of medical device manufacturing experience supporting NPI, Design Transfer, manufacturing process development and readiness, PFMEA, ECO/ECN, Windchill, BOM/configuration management, and FDA/ISO-regulated manufacturing environments.
- 5+ years of Medical device Manufacturing experience
- 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.
Preferred:
- Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control.
- Previous medical device experience.
Benefits: Danta offers a compensation package to all W2 employees that are competitive in the industry. It consists of competitive pay, the option to elect healthcare insurance (Dental, Medical, Vision), Major holidays and Paid sick leave as per state law.
The rate/ Salary range is dependent on numerous factors including Qualification, Experience and Location.
