Manufacturing Engineer II

Top 3 technical skills that are required for the role: 1.  Experience with ERP systems – SAP 2.  Experience with EUMDR 3.  Experience with change control in Medical Device Quality System Â

Education Required:

Bachelors Degree in Engineering discipline and at least 2 years of relevant experience providing direct manufacturing process support, OR Masters’ Degree and less than 2 years of relevant experience in a manufacturing environment providing direct manufacturing process support. Years’

Experience Required:

 2 years of relevant experience providing direct manufacturing process support  Provides shop floor support for manufacturing methods and processes in machining, metal finishing and assembly operations for assigned product lines. Maintains Manufacturing Process Planning documentation and insures the accuracy of labor standards. Initiates improvements in current manufacturing methods and processes to improve part quality, schedule performance and to reduce manufacturing costs.  Completes activities of the change control policy and Corrective and Preventive Action (CAPA) system in accordance with the company Corporate CAPA system. Completes activities of Lean Sigma projects and process improvements. Provides technical support to purchasing personnel and suppliers by interpreting product drawings, initiating the development of manufacturing drawings and resolving technical production problems. Proactively execute and support development of validation/qualifications studies. Determine strategy with appropriate teams and ensure that groups are involved early on in the needs of the engineering group. Responsible for the investigation of change requests received in the Manufacturing Engineering department, their rejection or approval, development and implementation of any process changes and proper documentation of any such changes. Working with the appropriate groups; maintains manufacturing process sheets for all machining, assembly, and finishing operations. Makes appropriate changes in manufacturing methods, processes and Manufacturing Process Planning documentation when dictated by engineering drawing changes. Documents all changes through the appropriate change control system. Coordinates entry of all master data for assigned product lines. This may include Purchase Requests, Capital Appropriation Request, Inventory Approval Forms, Material Masters, Bills of Material, routings, production versions, work centers, and document information records. Coordinates update of production order data as needed Initiates improvements in current manufacturing methods and processes to improve part quality, schedule performance and to reduce manufacturing costs.  Performs other duties as assigned. Â

Requirements:

Working knowledge of industry standards and regulatory requirements (including but not limited to:

ISO 13485, ISO 14971, MDD 93/42

EEC, PAL, CMDR, and 21 CFR Part 820). Understands impact of compliance to the requirements and how it relates to their job, or is aware of resources available to them to assist with determining impact. Strong communication skills, both oral and written Good interpersonal skills Ability to work in a fast paced environment Ability to work well under pressure and maintain positive, enthusiastic attitude Eagerness to learn and expand responsibilities Ability to work effectively in a team environment and build strong working relationships. Willingness to participate in continuous improvement activities