Manufacturing Engineer Job at Katalyst CRO in Town of Skaneateles

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Location: Skaneateles, NY

Overview

Manufacturing Engineer position focused on supporting medical device manufacturing in a fast-paced, collaborative environment. The role emphasizes problem solving, cross-functional teamwork, and continuous improvement to deliver high-quality, life-saving products.

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.
• Collaborate with project teams and established work processes; proactively identify creative methods to achieve desired performance.
• Represent manufacturing on R&D project core teams, ensuring deliverables, coordinating with internal stakeholders, and maintaining productivity.
• Develop and maintain manufacturing process documentation (e.g., Manufacturing Process Specifications, Device History Records, Tooling/Equipment Specifications, Preventive Maintenance, Calibration) through the 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 drive Continuous Improvement projects impacting Safety, Quality, Delivery, Productivity, and Cost.
• Perform and document Impact Assessments and Corrective Actions for equipment remediation related to 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 manufacturability and ease of assembly from raw materials to finished products.
• Leverage Subject Matter Experts during problem-solving exercises; provide scenarios to evaluate total cost and 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 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 modeling, schematic drafting, and electrical design is a plus.
• Knowledge or experience in computer-based automated testing.

Job details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Engineering and Information Technology
• Industries: Retail, Appliances, Electrical, and Electronics Manufacturing, and Civil Engineering

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