Katalyst CRO
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Manufacturing Engineer III
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Katalyst CRO . This job was posted 7 months ago. Get AI-powered advice on this job and more exclusive features. Responsibilities
Work within cross-functional project teams including Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to maintain and improve manufacturing processes for surgical products in the medical device industry. Design, specify, develop, and purchase manufacturing tooling, fixtures, and equipment. Manage the implementation and validation of new or modified manufacturing processes and equipment to support the manufacture of integra products. Support and guide transfers internally within the plant and externally with suppliers. Support the selection and validation of replacement materials such as polymers, metals, and adhesives used in manufacturing. Write and implement Manufacturing Procedures and Work Instructions. Create, update, and maintain BOMs, Routers, and DMRs. Provide process engineering expertise to resolve manufacturing-related problems with existing products and processes. Champion process improvements for rework, scrap, and labor variance reduction/elimination. Support Material Review Board processes by investigating and resolving manufacturing and supplier quality concerns. Identify and implement innovative manufacturing technologies based on industry best practices. Represent the Manufacturing Engineering group on strategic projects in Manufacturing and Sourcing. Requirements
Bachelor's degree in Mechanical, Manufacturing, Materials, Biomedical Engineering, or equivalent. Minimum of 6 years of engineering industry experience. Experience in the medical device industry. Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ, OQ, and PQ qualifications for medical devices. Working knowledge of manufacturing processes such as metal processing, plastics processing, and mechanical assembly. Preferred: Knowledge of machine and tool design, equipment design, and startup of new equipment. Preferred: Experience working in a cleanroom environment. Six Sigma certification or knowledge. Ability to troubleshoot and analyze manufacturing processes to improve uptime, yield, efficiencies, and quality. Experience with Lean Manufacturing and Continuous Improvement methods is preferred. Knowledge of financial analysis for product costs, project valuation, and capital purchases. Strong communication and team-building skills. Experience with Agile and Oracle data systems is preferred. This position is based in Mansfield, MA, requiring onsite presence 40 hours/week and up to 10% domestic travel. Additional Details
Seniority level: Mid-Senior level Employment type: Contract Industry: Pharmaceutical Manufacturing This job posting may be expired or no longer accepting applications. Please verify the current status directly on the job platform.
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Manufacturing Engineer III
role at
Katalyst CRO . This job was posted 7 months ago. Get AI-powered advice on this job and more exclusive features. Responsibilities
Work within cross-functional project teams including Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to maintain and improve manufacturing processes for surgical products in the medical device industry. Design, specify, develop, and purchase manufacturing tooling, fixtures, and equipment. Manage the implementation and validation of new or modified manufacturing processes and equipment to support the manufacture of integra products. Support and guide transfers internally within the plant and externally with suppliers. Support the selection and validation of replacement materials such as polymers, metals, and adhesives used in manufacturing. Write and implement Manufacturing Procedures and Work Instructions. Create, update, and maintain BOMs, Routers, and DMRs. Provide process engineering expertise to resolve manufacturing-related problems with existing products and processes. Champion process improvements for rework, scrap, and labor variance reduction/elimination. Support Material Review Board processes by investigating and resolving manufacturing and supplier quality concerns. Identify and implement innovative manufacturing technologies based on industry best practices. Represent the Manufacturing Engineering group on strategic projects in Manufacturing and Sourcing. Requirements
Bachelor's degree in Mechanical, Manufacturing, Materials, Biomedical Engineering, or equivalent. Minimum of 6 years of engineering industry experience. Experience in the medical device industry. Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ, OQ, and PQ qualifications for medical devices. Working knowledge of manufacturing processes such as metal processing, plastics processing, and mechanical assembly. Preferred: Knowledge of machine and tool design, equipment design, and startup of new equipment. Preferred: Experience working in a cleanroom environment. Six Sigma certification or knowledge. Ability to troubleshoot and analyze manufacturing processes to improve uptime, yield, efficiencies, and quality. Experience with Lean Manufacturing and Continuous Improvement methods is preferred. Knowledge of financial analysis for product costs, project valuation, and capital purchases. Strong communication and team-building skills. Experience with Agile and Oracle data systems is preferred. This position is based in Mansfield, MA, requiring onsite presence 40 hours/week and up to 10% domestic travel. Additional Details
Seniority level: Mid-Senior level Employment type: Contract Industry: Pharmaceutical Manufacturing This job posting may be expired or no longer accepting applications. Please verify the current status directly on the job platform.
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