New 
USA - Manufacturing Engineer I - CTQ
 Equiliem | |
 United States, New York, Skaneateles | |
 Mar 14, 2025 | |
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Manufacturing Engineer
Open to Remote/Hybrid: NO Work Schedule: 1st shift Length of Contract: 1 yr possibly longer...maybe 2 Possible Contract to Hire Role? no Interview process: (Teams/Onsite, Length, Rounds, Team involved) Teams or onsite 3 people involved Top 3-5 Must Have Non-negotiable Skills Required 1. Validation and verification 2. Procedure updates 3. Drawing updates Is a bachelor's degree Required? no but preferred How many years of recent experience does this person need to have? 1 or more Nice to Have Skills 1.previous medical field exp 2.GDT 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 working 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. What You'll Be Doing 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. Works with project teams and established work processes and proactively finds creative methods to reach desired performance levels. Represent manufacturing on R&D project core teams, responsible for 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, Preventative 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's associated with out of tolerance calibration results. Proactively identify and address safety related issues through 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 finish products. Leverage Subject Matter Experts during problem solving exercise. Provide multiple what-if scenarios to find the best total cost solution with financial impacts and emphasis on delivery timelines. Uses existing tools and best practices to report and track product and process metrics. Informs others proactively about developments or issues that affect their work, and their ability to meet commitments. What You'll Bring Bachelor's Degree in Engineering. 0-2+ years of experience Preferred: Experience in the Medical Device or a similar regulated industry. Knowledge or experience in SAP, CAD modeling, schematic drafting, and electrical design knowledge is a plus. Knowledge or experience in computer based automated testing. | |