Manufacturing Engineer

Responsibilities

• Contribute as the chemical, polymer, composite processing, and automation subject matter expert at the site within cross-functional teams across the site.
• Hands on design and development of polymer and chemical processes and equipment.
• Design, plan, and implement equipment qualification, equipment validation, and product validation projects.
• Assist in developing documents, specifications, protocols, SOPs, batch records, work instructions and test procedures.
• Work with outside vendors and design development partners.
• Suggest solutions to manufacturing challenges based on experience, experimental data and implement those recommendations working closely with cross-functional partners.
• Develop and protect intellectual property associated with product or processes.
• Maintain compliance to applicable regulatory requirements and internal quality policies
• Establish the equipment and facilities to support leading instrumentation qualifications and user requirement specification.
• Assist with design FMEA implementation and lead process of FMEA. 
• Execute operational and product qualifications and provide summary reports of findings.
• Lead capital projects with primary responsibility to meet budget requirements.
• Sustain ongoing continuous improvement related to facilities, equipment and product realization.
• Other duties as assigned

Requirements:

• Minimum of 5+ years of relevant engineering experience. Experience with firms supplying materials to medical device makers and pharmaceutical firms preferred.
• Bachelor Degree in engineering field covering Materials Science, Chemical Engineering, Plastics Engineering, Bioengineering, or Mechanical Engineering field. Master's degree in similar field of study is considered a plus.
• Demonstrated ability to manage capital projects. 
• Proficiency with cGMP under FDA, ICHQ7, ISO 9001 or ISO 13485 environments.
• Demonstrated capability to develop plant and processing improvements using a broad knowledge base in polymer engineering/processing, chemical and mechanical engineering.
• Demonstrated experience with equipment software, design and implementation of automation projects at a manufacturing site.
• Working knowledge of ISO, ASTM, GDP, cGMP, and design controls is highly desirable.
• Excellent organizational, written, and verbal communication skills is a requirement.
• Experience using design of experiments and the implementation of six sigma principles to optimize processes is highly desirable.
• Experience processing biomaterials, especially resorbable polymers is a plus.
• Understand OSHA and Regulatory laws and compliance.
• Experience working on- reactors, pumps, tanks, filters, heat exchangers, glass manufacturing, extrusion, etc. 
• Must be able to communicate effectively in written and verbal form 
• Must be able to work cross functionally on teams involving R&D, Quality, Supply Chain, Production, Sales.
• Working knowledge of HAZOP and process safety reviews, including risk assessments.
• Ability to read and follow detailed instructions and record information clearly and accurately, including Piping & Instrumentation Diagrams (P&ID).
• Familiarity with Excel, Word, MS Project, CAD software and other computer software.