This position has responsibility for interfacing with Haemoscope suppliers of equipment, subcomponents, reagents, accessories and spare parts. Recommend product design changes and implement changes to manufacturing processes to achieve significant quality or cost improvements. Requires participation in new product development programs, identifying design-for-manufacturability issues and ensuring these issues are addressed prior to release.
• Understand, define and approve (with management direction) all supplier production processes used for products and components.
• Provide support in the implementation of all changes affecting suppliers for product line components.
• Assess, investigate, troubleshoot and recommend changes for production processes.
• Write documents and make documentation changes affecting products and processes, write and execute validation protocols, and write ECO’s for release to manufacturing.
• Identify critical components and associated critical performance characteristics for analyzer and reagents and providing for appropriate controls to ensure that performance characteristics are met.
• Participate in supplier audits, including supply chain investigations for critical parts and components.
• Participate in facilitating tech transfer between contract manufacturers ensuring a secure supply chain for a growing product line.
• Ensure that production processes and systems as well as product designs produce the highest possible quality and lowest possible cost.
• Participate as a team member on larger manufacturing projects and help lead projects with specific focus on small scope projects, as assigned by manager.
• Help drive multiple improvement programs through to implementation and follow-up on the results achieved, including quality monitoring and actions, production efficiency, improvement of assembly methods, and documentation and implementation of approved changes
• Under the direction of the senior process engineer, assist in investigations of product-related problems reported from a variety of sources: internal manufacturing at Haemoscope (non-conforming product), problems reported from suppliers during external manufacturing processes, issues requiring investigation of Haemoscope supply chain (subcontractors) to determine root cause and resolution, problems encountered by customers in the use of the Haemoscope product (complaints, not performing to specifications, etc.), reports from service and repair personnel, and CAPA and audit reports.
Required Bachelor's Degree Engineering
Required 3 years Experience in a manufacturing environment; medical device or other FDA regulated industry experience required.
Required Other Equivalent combination of experience and training
Required Other Experienced in Process/Product Validation requirements and techniques, especially as applied to medical device and /or pharmaceutical (Pre-Approval Inspection) manufacturing.
Required Other Highly experienced with computer programs such as Microsoft Excel, Visio, Project and Word.
Preferred Other Experience with ERP systems, TQM, Lean Manufacturing and Six Sigma methodologies
Licenses and Certifications:
Required Must be knowledgeable about FDA QSR regulations and ISO 13485 requirements.
Candidate Background: Skills, Knowledge & Ability: Minimum requirements:
Required Experience in a manufacturing environment; medical device or other FDA regulated industry experience required.
Required Equivalent combination of experience and training
Required Experienced in Process/Product Validation requirements and techniques, especially as applied to medical device and /or pharmaceutical (Pre-Approval Inspection) manufacturing.
Required Highly experienced with computer programs such as Microsoft Excel, Visio, Project and Word.
PreferredExperience with ERP systems, TQM, Lean Manufacturing and Six Sigma methodologies