This position will support Global Supply Chain by developing and implementing end-to-end automated process technology resulting in robust, sustainable, integration of automated manufacturing processes, while improving Quality, Reliability, Process Capability, and/or Environmental Health and Safety. This role will interact with cross-functional teams to implement advanced processes in global environments. Key elements of this role include the development of innovative equipment and new processes required for launch of new products, and associated pilot process scale up and/or transfers using DMAIC, design for manufacturing and design to cost methodologies.
In this role the candidate will:
Support lead engineers in identifying, sourcing, and evaluating new technology applications resulting in capable, simple, and automated manufacturing processes for global applications.
Work with internal subject matter experts (SMEs) and external engineering design firms in the development, design and validation of automation fixtures, tooling and manufacturing aids for Pilot and Commercial manufacturing.
Work in a dynamic, cross-functional design team environment which includes product development, regulatory, quality and manufacturing to ensure project objectives are met.
Identify and implement process and/or equipment improvements in ergonomics, mistake proofing, lean manufacturing and capacity for Pilot and Commercial manufacturing.
Formulate operational requirement specifications in collaboration with cross-functionally across all sites.
Review and update the equipment design, drawings and documentation.
Work closely with the maintenance department to stablish a preventative maintenance and calibration requirements for new equipment.
Periodically provide updates and plans to sponsors, stakeholders and management.
Execute experiments with limited to no supervision and provide results in a concise and controlled format (Test Report, Technical Summary, Lab Notebook, etc.).
Bachelor's degree in an engineering discipline is required.
Degree in Electrical or Mechanical engineering is preferred.
Some experience designing, implementing, and hands-on troubleshooting of automated equipment as well as hands on application of automation in a highly regulated manufacturing environment (preferred).
Ability to design simple to complex manufacturing aids and fixtures using ProE and/or SolidWorks.
Demonstrated hands-on approach, comfortable with prototyping and feasibility testing.
Proficiency in process development and translation into clear, concise specifications, such as User Requirements, Functional Specification, etc.
Experienced in the development of manufacturing process sheets and product costing.
Familiar with lean manufacturing, mistake proofing principals and six sigma methodologies.
Strong communication and interpersonal skills.
Possesses ability to handle multiple tasks with attention to detail.
High energy individual that has excellent leadership, teamwork and influencing skills.
Knowledge of cGMP and FDA guidelines and Validation.
E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.