Manufacturing Engineering is responsible for developing manufacturing processes, qualifying changes to products, running validations, and associated tools. Reviews new design changes for manufacturability. Designs process improvements to reduce product cost, process cycle time and improved product quality.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Create documentation to support new and improved manufacturing processes
Write and perform process validations
Make recommendations for equipment purchases based upon manufacturing needs
Perform IQ/OQ/PQ as required on equipment
Disposition NCRs and CAPAs as assigned
Perform experiments including but not limited to DOEs to characterize and improve processes Interface directly with assemblers, production supervisors, leads, engineers, and management on a routine basis
Coordinate with suppliers and external resources needed in developing and implementing new processes
Work closely with R&D and Manufacturing to capture and interpret design intent in order to refine and improve processes Facilitate excellent communications between all team members Responsible for communicating business related issues or opportunities to next management level For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets Performs other duties assigned as needed
Skills:
Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
Works on projects of moderate scope and complexity
Identifies possible solutions to a variety of technical problems and takes actions to resolve
Applies judgment within defined parameters
Receives general guidance may receive more detailed instruction on new projects
Work reviewed for sound reasoning and accuracy.
EXPERIENCE 3-5 years related work experience, preferably in a medical device manufacturing environment preferred
Excellent hands on communication and interpersonal skills
Experienced in MS Word, Excel, and Project Experience in Design for Manufacturing (DFM), Design of Experiments (DOE) and product/process. Failure Mode and Effects Analysis (FMEA) Strong Lean Manufacturing background preferred. Must be able to multitask and operate in a fast-paced environment with minimal training and supervision. Strong written, verbal, and interpersonal skills. Ability to effectively interact with all levels of employees and management, both in the Manufacturing group and cross functionally
Excellent computer skills including advanced working knowledge of Microsoft Office (Word, Excel, Outlook, etc.) Understanding of regulations related to FDA, GMP/MDD, and ISO preferred
Education:
Bachelor degree required - some majors that would fit the role are below with the priority also in order Mechanical Engineer, Electrical Engineer, or Industrial Engineer