Senior Manufacturing Engineer - Digital Surgery

Acumed LLC

Addison, TX, United States
**
5+ years manufacturing engineering experience
Fda and iso 13485 regulatory knowledge
Cnc machining and 3d printing expertise
** Acumed LLC is seeking a Senior Manufacturing Engineer for their medical device production in Addison, TX. The role involves leading the development and improvement of manufacturing processes, ensuring compliance with regulatory standards, and fostering a quality-first culture. **

Job Summary

  • The Senior Manufacturing Engineer is responsible for supporting the life cycle of Acumed's medical devices by meeting operational objectives in production.
  • This role owns continuous improvement of existing processes through the elimination of waste and the adoption of new methods of manufacturing to drive Cost of Goods Sold and On Time Delivery targets.
  • The ideal candidate must have a passion for manufacturing and be effective in a quality-first, highly regulated environment with excellent verbal communication skills.

Matching Summary

Match Score: 75

** Acumed LLC is seeking a Senior Manufacturing Engineer for their medical device production in Addison, TX. The role involves leading the development and improvement of manufacturing processes, ensuring compliance with regulatory standards, and fostering a quality-first culture. **

Skills & Requirements

Must-have

  • 5+ years manufacturing engineering experience
  • FDA and ISO 13485 regulatory knowledge
  • CNC machining and 3D printing expertise
  • Process validation IQ OQ PQ proficiency
  • Statistical analysis with Minitab or JMP

Nice-to-have

  • Patient-specific manufacturing workflow experience
  • Mentorship of junior engineers and technicians
  • Go and see shop floor mentality
  • Experience with anodization and passivation
  • Advanced CAD software proficiency

Key Requirements

  • Bachelor's degree in Engineering
  • 5+ years experience in manufacturing engineering
  • Knowledge of FDA regulations and ISO 13485 standards
  • Experience in regulated manufacturing industry
  • US work authorization required

Work Rights

Not specified

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