Remote Position

[Remote] Manufacturing Engineer

🌍 Remote Β· United States πŸ’Ό Full-time

Note: The job is a remote job and is open to candidates in USA. Katalyst CRO is a company specializing in manufacturing processes, and they are seeking a Manufacturing Engineer to lead the development of manufacturing processes from planning through production launch. The role involves collaborating with various teams to improve manufacturability, quality, and cost, while driving continuous improvement initiatives.

Responsibilities

  • Lead manufacturing process development from planning through production launch and ramp-up
  • Develop work instructions, SOPs, process flows, standardized work, cycle time studies, and launch readiness documentation
  • Support production line requirements, workstation concepts, tooling, fixtures, equipment interfaces, and process documentation
  • Collaborate with Engineering, Operations, Quality, Supply Chain, Facilities, Maintenance, and EHS teams
  • Support line layout, equipment placement, ergonomics, material presentation, capacity, and production flow improvements
  • Participate in DFM/DFA reviews to improve manufacturability, quality, and cost
  • Support PFMEA, Control Plans, APQP/PPAP, process validation, production trials, audits, and readiness reviews
  • Support equipment installation, commissioning, process validation, run-at-rate, ramp-up stabilization, and operational handover
  • Analyze OEE, cycle time, downtime, yield, scrap, rework, labor utilization, and throughput performance
  • Drive continuous improvement initiatives using Lean Manufacturing, Kaizen, 5S, VSM, SMED, Poka-Yoke, and structured problem-solving methods
  • Evaluate supplier manufacturing feasibility and production readiness

Skills

  • Bachelor's degree in manufacturing engineering, Mechanical Engineering, Industrial Engineering, Production Engineering, or related field
  • 7+ years of experience in Manufacturing Engineering, Production Launch, Process Development, Industrialization, or Manufacturing Operations Support
  • Experience in large-scale manufacturing environments
  • Strong understanding of manufacturing processes, production systems, tooling, fixtures, workstations, and shop-floor execution
  • Experience working with cross-functional teams across Engineering, Operations, Quality, Supply Chain, Equipment, Controls, Facilities, and EHS
  • Manufacturing Process Development
  • Production Launch & Ramp-up
  • SOPs & Standardized Work
  • Cycle Time Studies
  • Line Balancing
  • OEE Analysis
  • PFMEA
  • Control Plans
  • APQP / PPAP
  • Process Validation
  • Lean Manufacturing
  • Kaizen
  • 5S
  • VSM
  • SMED
  • Poka-Yoke
  • Root Cause Analysis
  • Material Flow
  • PFEP
  • Equipment Installation & Commissioning
  • DFM / DFA
  • Manufacturing Documentation

Benefits

  • Work model: remote, onsite

Company Overview

  • Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide. It was founded in undefined, and is headquartered in South Plainfield, New Jersey, USA, with a workforce of 51-200 employees. Its website is http://katalysthls.com.
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