Manufacturing Process Engineer

4 days ago


New Haven, Connecticut, United States LanceSoft Full time
Job Description

LanceSoft is seeking a highly skilled Manufacturing Engineer II to join our team. As a key member of our engineering team, you will be responsible for designing and implementing manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.

Key Responsibilities:
  • Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
  • Design arrangement of machines within plant facilities to ensure efficient and productive layout.
  • Develop manufacturing processes that are applicable to statistical process control.
  • Provide guidance to engineering regarding design concepts and specification requirements.
  • Ensure processes and procedures are in compliance with regulations.
Requirements:
  • Bachelor's degree in engineering or equivalent required.
  • Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
  • Experience with FDA 21 CFR part 820, ISO 13485, ISO 14971, and GMP.
  • Knowledge of DFMEA and PFMEA, process mapping, and critical to quality reviews.
Preferred Qualifications:
  • BS in Engineering.
  • Experience with statistical analysis tools, including Minitab, DOE, process capability, measurement system, and confidence interval analysis.
  • Process V&V, IQ, OQ, PQ, and TMV.
  • CAPA, root cause investigations, quality tools, including DMAIC, A3, 5 Whys, 6 M, Ishikawa Diagram, and Pareto Charts.
About LanceSoft:

LanceSoft is a leading provider of innovative solutions for the manufacturing industry. We are committed to delivering high-quality products and services that meet the needs of our customers.



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