Katalyst Healthcares and Life Sciences
Manufacturing Engineer
Katalyst Healthcares and Life Sciences, Skaneateles, New York, United States, 13152
Job Description:
You are a problem solver. Complex projects or unexpected challenges are opportunities to apply your considerable abilities. Whether working independently or with a trusted team, you are always ready to tackle a project and find solutions. Your talent is needed across a wide variety of industries. As a Manufacturing Engineer, you have a broad array of career choices, but you are motivated by the opportunity to work in a company that supports innovation, professional development, and a purposeful mission. We are a team of inquisitive individuals who embrace a collaborative environment to take on sophisticated challenges that meet the needs of our patients. We often need to change directions and respond to issues to avoid disruptions in our fast-paced manufacturing environment. Together, we build and maintain a positive work environment. Our team is dedicated to quality. Delivering life-saving products is about getting them right, and our technical expertise and experience in a manufacturing environment empower us to meet that challenge. When you join us, you will work with a team of committed individuals who trust each other to deliver on the tasks at hand. We support innovation and out-of-the-box thinking, balanced with collaboration across functions and other teams. Our leadership understands the need for continuous education and provides opportunities for further development. Responsibilities:
Member of cross-functional Electronics "Gemba" Team with responsibility for up to 8 medical device manufacturing assembly lines. Execute Process and Equipment Validation/Verification Strategies for new or changing manufacturing process elements. Execute Engineering Builds and assist with Material Qualification Planning to support new or changing component requirements. Work with project teams and established work processes, proactively finding creative methods to achieve desired performance levels. Represent manufacturing on R&D project core teams, ensuring deliverables, collaborating with internal stakeholders, and ensuring productivity. Develop and maintain manufacturing process documentation, including but not limited to Manufacturing Process Specifications, Device History Records, Tooling/Equipment Specifications, Preventive Maintenance, and Calibration procedures through Engineering Change Management (ECM) process. Perform and document root-cause analysis for Non-Conforming Material Reports. Summarize and report on departmental Safety, Quality, Delivery, Productivity, and Cost performance measures. Use Lean/Six Sigma methodology to identify and drive Continuous Improvement Projects to enhance Safety, Quality, Delivery, Productivity, and Cost performance measures. Perform and document Impact Assessments and Corrective Actions for Equipment Remediation associated with out-of-tolerance calibration results. Proactively identify and address safety-related issues through the Near Miss Reporting Process. Review product designs with R&D, Sustaining, and AME engineers for optimized manufacturability and ease of assembly, from raw material to finished products. Leverage Subject Matter Experts during problem-solving exercises. Provide multiple "what-if " scenarios to find the best total cost solution with financial impacts and Client on delivery timelines. Use existing tools and best practices to report and track product and process metrics. Proactively inform others about developments or issues that affect their work and their ability to meet commitments. Requirements:
Bachelor's degree in engineering. 0-2+ years of experience. Experience in the Medical Device or a similar regulated industry. Knowledge or experience in SAP, CAD modelling, schematic drafting, and electrical design is a plus. Knowledge or experience in computer-based automated testing.
You are a problem solver. Complex projects or unexpected challenges are opportunities to apply your considerable abilities. Whether working independently or with a trusted team, you are always ready to tackle a project and find solutions. Your talent is needed across a wide variety of industries. As a Manufacturing Engineer, you have a broad array of career choices, but you are motivated by the opportunity to work in a company that supports innovation, professional development, and a purposeful mission. We are a team of inquisitive individuals who embrace a collaborative environment to take on sophisticated challenges that meet the needs of our patients. We often need to change directions and respond to issues to avoid disruptions in our fast-paced manufacturing environment. Together, we build and maintain a positive work environment. Our team is dedicated to quality. Delivering life-saving products is about getting them right, and our technical expertise and experience in a manufacturing environment empower us to meet that challenge. When you join us, you will work with a team of committed individuals who trust each other to deliver on the tasks at hand. We support innovation and out-of-the-box thinking, balanced with collaboration across functions and other teams. Our leadership understands the need for continuous education and provides opportunities for further development. Responsibilities:
Member of cross-functional Electronics "Gemba" Team with responsibility for up to 8 medical device manufacturing assembly lines. Execute Process and Equipment Validation/Verification Strategies for new or changing manufacturing process elements. Execute Engineering Builds and assist with Material Qualification Planning to support new or changing component requirements. Work with project teams and established work processes, proactively finding creative methods to achieve desired performance levels. Represent manufacturing on R&D project core teams, ensuring deliverables, collaborating with internal stakeholders, and ensuring productivity. Develop and maintain manufacturing process documentation, including but not limited to Manufacturing Process Specifications, Device History Records, Tooling/Equipment Specifications, Preventive Maintenance, and Calibration procedures through Engineering Change Management (ECM) process. Perform and document root-cause analysis for Non-Conforming Material Reports. Summarize and report on departmental Safety, Quality, Delivery, Productivity, and Cost performance measures. Use Lean/Six Sigma methodology to identify and drive Continuous Improvement Projects to enhance Safety, Quality, Delivery, Productivity, and Cost performance measures. Perform and document Impact Assessments and Corrective Actions for Equipment Remediation associated with out-of-tolerance calibration results. Proactively identify and address safety-related issues through the Near Miss Reporting Process. Review product designs with R&D, Sustaining, and AME engineers for optimized manufacturability and ease of assembly, from raw material to finished products. Leverage Subject Matter Experts during problem-solving exercises. Provide multiple "what-if " scenarios to find the best total cost solution with financial impacts and Client on delivery timelines. Use existing tools and best practices to report and track product and process metrics. Proactively inform others about developments or issues that affect their work and their ability to meet commitments. Requirements:
Bachelor's degree in engineering. 0-2+ years of experience. Experience in the Medical Device or a similar regulated industry. Knowledge or experience in SAP, CAD modelling, schematic drafting, and electrical design is a plus. Knowledge or experience in computer-based automated testing.