Manufacturing Process Specialist II

2 weeks ago


Charlton, Massachusetts, United States KARL STORZ Endoscopy - America Full time
Position Overview

Role Summary

This role is designed to deliver practical engineering assistance to production operations aimed at creating top-tier medical devices. The individual in this position will spearhead initiatives for continuous enhancement, document and refine manufacturing methodologies, devise engineering solutions for production challenges, and facilitate the introduction of new products and processes.

Core Responsibilities

  • Collaborate with Global Research & Development (GRD), Project Engineering, Operations, Quality Assurance, Maintenance, and other essential departments to initiate and sustain manufacturing processes.
  • Design and develop tooling and fixtures, including necessary qualification procedures.
  • Provide support for current equipment and processes, including troubleshooting and validation of processes.
  • Select equipment and infrastructure, ensuring compliance through qualification activities (IQ/OQ/PQ).
  • Drive improvements in workflow and quality before, during, and after the launch of serial production.
  • Implement strategies for cost reduction.
  • Prepare and submit Engineering Change Orders.

Essential Qualifications

  • Bachelor's Degree in a Technical or Engineering field.
  • 3 to 5 years of engineering experience within the medical device manufacturing sector.
  • Experience in process development and automation of assembly operations.
  • Strong problem-solving skills, including methodologies such as SSGB/SSBB, A3, DMAIC, and Kaizen.
  • Expertise in identifying, designing, and qualifying equipment, tooling, and fixtures.
  • Ability to conduct Capital Expense ROI assessments and proposals.
  • Proficient in MS Office, particularly in data analysis focused on process yield monitoring and enhancement.
  • Familiarity with Solidworks for creating technical drawings.

Preferred Experience

  • Experience working with global teams, with a readiness to travel internationally.
  • Integration of collaborative robots into existing manufacturing workflows.
  • Knowledge of Quality Control and Inspection processes.
  • Prior experience in a regulated manufacturing environment.

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