Tooling Process Improvement Engineer

Job Summary

Support the design and implementation of progressive tooling dies, quality & manufacturing equipment. Contribute to upstream process improvements through use of Lean Six Sigma tools and identify root causes in product rejection. Works as part of a global team and provide technical support to various functional teams.

Essential Duties and Responsibilities

• Support Engineering and Tooling to update and approve prints for components, equipment, and/or new designs, review, control, and track print updates for accuracy.
• Interact with engineering, management, site, and corporate team members, and/or vendors to develop engineering controls or required process improvements.
• Plan, coordinate, or perform modifications, improvements, or new initiatives for new or existing products, equipment, or processes.
• Collaborate with Tooling Supervisor to find solutions in tooling design, improvements, preventative maintenance opportunities, or process parameters.
• Support current and future projects as related to measurement devices; qualify new or improved measurement devices to support production and quality.
• Conduct and design engineering studies and ensure all changes are appropriately documented in change controls or other methods of documenting change.
• Apply lean manufacturing initiatives, identifying product failure reduction opportunities, standardizing processes and parameters, and identifying cost savings potential.
• Support projects and initiatives stemming from the Local and Global Process Engineering Team.
• Research and analyze data to determine optimal processing conditions.
• Contributes to continuous process improvement efforts.
• Use statistical methods and good documentation skills to ensure evaluation is completed with the necessary information.
• Initiate, support and execute process related CAPAs for Quality Initiatives or Customer Complaints.
• Must have good communication skills while working with operators, engineers, and management.

Additional Responsibilities

Education

• Bachelor's degree in engineering required

Work Experience

• Minimum of 1-3 years equivalent experience in cGMP/Pharmaceutical manufacturing environment.
• Minimum 1-3 years’ experience of AutoCAD, SolidWorks, and GD&T.
• Six Sigma and Lean Manufacturing experience preferred
• Project management, ability to work independently required
• Machining, Tooling, Engineering Materials, and Finishing (plating and surface treatments) experience preferred

Preferred Knowledge, Skills and Abilities

• General knowledge of OSHA/EPA/safety regulations, manufacturing, and process automation.
• Maintain an awareness of “state of the art” technology as it applies to our industry. Take part in educational programs pertinent to process projects.
• Working knowledge of business and shop floor systems to effectively manage operations; prefer SAP, Minitab, and MS Office applications.
• Experience working with ISO9000, FDA and cGMP required.
• Understanding and experience in use of Lean manufacturing principles.
• Ability to write routine reports, correspondence, and process documents.
• Excellent organizational and communication skills.
• Works independently with minimal guidance.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

License and Certifications

• Manufacturing\Six Sigma Green Belt Certification preferred

Travel Requirements

Physical Requirements

Additional Requirements

• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and fingers to operate office equipment (ie phones, computers, copies, etc.).
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• The ability to be able to lift and carry various items up to 40 pounds.
• The employee is occasionally exposed to wet and/or humid conditions and fumes or airborne particles.
• The employee occasionally works near moving mechanical parts and or equipment.
• The employee occasionally works in clean room environments requiring special gowning and training to operate in these environments.
• The noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required as posted in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading, or writing, organization, problem solving, understand direction, etc.