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NPD Engineer
Position is the lead role for the New Product Development Quality function and a strategic partner with new and existing Product Development Engineering teams. This position is a critical liaison to success of new product launches and changes to existing products which requires building strong relationships. Position will require utilizing expertise and solid working knowledge of Quality and Manufacturing processes to engage and effectively influence Engineering and Management Levels internal and external to the Company. Position develops new product quality control plans for Water Lab Product lines while providing direction and consultation for implementation of quality process control plans to Product Design Engineers, Process Design Engineers, Quality Engineers and Supplier Engineers. You will work as core team member on New Product Development teams to take projects from Concept to full production and implement necessary controls to ensure successful launch and manufacturing execution.
Job Duties:
• Develops, implements, and maintains New Product Quality processes and revises existing APQP Plans across multiple product lines incorporating benchmark and standardized processes across the Company while ensuring flawless product quality measures are instituted
• Is the Lead Quality Expert as member of New Product Development Team(s) to assure that all quality deliverables are completed on time
• Trains and Coaches others in APQP techniques and in the use of scientific approaches including statistical tools
• Audits NPD phase gate deliverables for regulatory and procedural compliance
• Identifies and drives execution on opportunities for improvement of new product launches based on historical like products
• Other miscellaneous assignments including traditional Quality Engineer duties
Minimum Requirements/Qualifications:
Job Knowledge:
• Extensive senior level quality engineering experience using quality systems and tools involving new product development
• Advanced knowledge of quality continual process improvement techniques in a Lean manufacturing environment and in statistical waste reduction techniques
• Proficient in process auditing with significant competency in analyzing. trouble shooting and resolving complex quality situations.
• Solid Technical Experience in driving quality improvement projects both internally and with suppliers
• Knowledgeable in advanced data collection, measuring, analysis, improvement and control
• Strong knowledge of manufacturing processes (assembly, weld, metal forming, paint, electrical assembly) and quality control methodologies and documentation
• Proficient in use of Microsoft Office Suite
• Working experience with the FDA Quality System Regulation (21CFR820), ISO 9000, ISO 13485 quality standards
• Knowledgeable of Advanced Product Quality Planning techniques and tools
Experience:
• BS degree required in Engineering or other technical field
• Project Manager experience preferred
• A minimum of two commercially successful new product deployments
• Advanced Level Quality Systems experience required
• Manufacturing or biomedical assessment activities strongly preferred
• Verbal and written communication skills including good persuasion skills required
• ASQ Quality Engineer Certification desirable
• Experience in medical device industry and products a plus
Job Duties:
• Develops, implements, and maintains New Product Quality processes and revises existing APQP Plans across multiple product lines incorporating benchmark and standardized processes across the Company while ensuring flawless product quality measures are instituted
• Is the Lead Quality Expert as member of New Product Development Team(s) to assure that all quality deliverables are completed on time
• Trains and Coaches others in APQP techniques and in the use of scientific approaches including statistical tools
• Audits NPD phase gate deliverables for regulatory and procedural compliance
• Identifies and drives execution on opportunities for improvement of new product launches based on historical like products
• Other miscellaneous assignments including traditional Quality Engineer duties
Minimum Requirements/Qualifications:
Job Knowledge:
• Extensive senior level quality engineering experience using quality systems and tools involving new product development
• Advanced knowledge of quality continual process improvement techniques in a Lean manufacturing environment and in statistical waste reduction techniques
• Proficient in process auditing with significant competency in analyzing. trouble shooting and resolving complex quality situations.
• Solid Technical Experience in driving quality improvement projects both internally and with suppliers
• Knowledgeable in advanced data collection, measuring, analysis, improvement and control
• Strong knowledge of manufacturing processes (assembly, weld, metal forming, paint, electrical assembly) and quality control methodologies and documentation
• Proficient in use of Microsoft Office Suite
• Working experience with the FDA Quality System Regulation (21CFR820), ISO 9000, ISO 13485 quality standards
• Knowledgeable of Advanced Product Quality Planning techniques and tools
Experience:
• BS degree required in Engineering or other technical field
• Project Manager experience preferred
• A minimum of two commercially successful new product deployments
• Advanced Level Quality Systems experience required
• Manufacturing or biomedical assessment activities strongly preferred
• Verbal and written communication skills including good persuasion skills required
• ASQ Quality Engineer Certification desirable
• Experience in medical device industry and products a plus
Please send cv to Recruitersall@fusionlifesolutions.com