Manufacturing Engineer
Manufacturing Engineering is responsible for developing manufacturing processes, qualifying changes to products, running validations, and associated tools.
RESPONSIBILITIES
- Reviews new design changes for manufacturability.
- Design 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
- 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
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.
- Understanding of regulations related to FDA, GMP/MDD, and ISO preferred
EDUCATIONS
- 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
