Job Description

Description

Responsible for planning and leading small to medium sized projects to improve quality and efficiency of existing manufacturing processes as well as the scale-up, validation, and transfer of new products into manufacturing. Specific responsibilities will include project planning using MS Project, equipment and process design or specification, process optimization using Six Sigma or equivalent methodologies, process validation, and the implementation of process and manufacturing documentation.

Manufacturing Engineer Job Duties:

• Investigates and implements improvements to manufacturing processes to improve quality and efficiency, ensuring that all regulatory requirements are satisfied.
• Review manufacturing trending reports to ensure processes remain in control, assist manufacturing in investigating processes that yield product in specification but out of control limits.
• Investigate non-conformance conditions and implement corrective actions.
• Work with Product Development teams to facilitate the successful scale-up, transfer, and validation of new products.
• Prepare new or modify existing procedures as necessary for product/process improvements and new product transfers.
• Determine Critical to Quality (CTQ) attributes of products and processes. Establish trending requirements to monitor performance of CTQ’s.
• Design and execute engineering and validation studies for process improvements and new products.
• Design and execute equipment qualifications for new or improved manufacturing processes.
• Represent Operations on multiple new product development teams.
• Ensure compliance with all pertinent safety teams and regulatory policies.
• Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
• Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
• Improves manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
• Assures product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes. Including PFMEA development.
• Provides manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
• Prepares product and process reports by collecting, analyzing, and summarizing information and trends.

Manufacturing Engineer Skills:

• Demonstrated technical skill and experience in process validation and equipment qualification.
• Excellent analytical and problem-solving skills, including previous experience with Statistical Process Control, root cause analysis.
• Experience in Lean Manufacturing, Minitab applications, and project leadership strongly preferred.
• Experience with plant layout / flow using 2D CAD.
• Above average communication skills, written and oral.
• Technical writing skills including experience writing manufacturing documentation (Batch Records, Material Specs, Bills of Material, etc).
• Mechanical design proficiency using SolidWorks or equivalent 3D CAD system.
• Experience as a project manager/planner, preferably using MS Project.
• Previous experience leading process improvement/new product transfer projects
• Dealing with Complex Matrix Organizations

Qualifications

• B.S. degree in Industrial or Mechanical Engineering
• 3 or more years of experience in a role responsible for process development and/or improvements
• Experience with new product development and its different stages
• Experience with technology transfer from different sites into local manufacturing
• Periodic travel may be required up to 20%