Manufacturing Engineeer

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Manage the design, acquisition, installation and commission of mechanical/electrical equipment, systems and parts to support manufacturing
• Perform process development and transfers from Engineering to Manufacturing
• Provides technical engineering support for repairing, troubleshooting and modifying equipment and systems
• Mechanical understanding of custom automation systems and their impact with consumables
• Establish and challenge manufacturing processes
• Functional testing on internal automated manufacturing equipment
• Execute engineering functions such as: Design Reviews, Measurement Systems Analysis, Design of Experiments, feasibility studies, process development, acceptance testing, and risk management
• Understand drawing functions including GD&T
• Develop inspection and measurement techniques
• Analyze advanced statistics to confirm or reject hypothesis
• Analyze test results, provide recommendations, and author summary reports
• Independently lead the creation of RFQ/URS documentation for injection molds and/or consumables automation systems
• Continuously improve internal and external supplier processes to reduce the time to market, enhance product quality, and decrease costs
• Develop and/or implement continuous improvement ideas and participate in the strategic Operations plans
• Manage outside vendor s with establishing relationships to provide equipment proposal, user requirement specification, development, installation, qualification and sustaining support of equipment and processes
• Manage qualifying and changes in raw materials, vendors and perform investigations for non-conformance events
• Designs and implements automated solutions to manufacturing challenges
• Provides QS validation input and support for new equipment and process validations including reviewing and executing Installation, Operation, and Performance Qualification Validations; including writing final reports

Qualifications

Education

• BA or BS degree, preferred in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Quality Engineering, Biomedical Engineering or Validation Engineering
• Lean Manufacturing and/or Six-Sigma Certification preferred but not required
• Certified Quality Engineering Certification preferred but not required

For level 4

Experience

• 10+ years of Biotech / Medical Device / Pharmaceutical industry experience

For level 5

Experience

• 12+ years of Biotech / Medical Device / Pharmaceutical industry experience
• High volume manufacturing experience in a regulated environment
• High proficiency with MS Office, MS Project, and MS SharePoint
• High proficiency with Minitab or other statistical analysis software
• Working knowledge of manufacturing automation systems and design practices
• Working knowledge of cGMP, GAMP, ISO 13485, and FDA 21 CFR, Part 820

Skills

• Working knowledge of microprocessor controls, utility distribution systems and process engineering
• Biotech / Medical Device / Pharmaceutical industry experience
• Basic knowledge of manufacturing automation systems and best design practice
• High proficiency with MS Office, MS Project, and MS SharePoint
• High proficiency with Minitab or other statistical analysis software
• Working knowledge of manufacturing automation systems and design practices
• Working knowledge of cGMP, GAMP, ISO 13485, and FDA 21 CFR, Part 820