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Senior Manufacturing Engineer

Senior Manufacturing Engineer

SciProMansfield, MA, US
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Job Description

Key Responsibilities

  • Develop and document detailed work instructions and assembly procedures from design specifications.
  • Train production operators and ensure adherence to process standards.
  • Design, build, and validate fixtures, tools, and gauges for assembly and measurement.
  • Plan and optimize manufacturing layouts, workflows, and equipment utilization to improve efficiency.
  • Oversee equipment safety, maintenance, and preventive repair programs.
  • Monitor process output, scrap, and yield; analyze and resolve production issues.
  • Lead root cause analysis and pFMEA for recurring or critical issues.
  • Collaborate with R&D and NPI teams on new product introductions and process validations (DOE, capability studies).
  • Support continuous improvement initiatives focused on yield, cycle time, and cost reduction.
  • Maintain compliance with ISO 13485, ISO 14971, and FDA QSR standards.
  • Support plant safety initiatives and complete assigned corrective actions.

Qualifications

  • Education : BS in Mechanical, Manufacturing, Industrial, or Electrical Engineering (or related).
  • Experience : 5–7 years in process development and production support, ideally in the medical device industry.
  • Skills :
  • Proficiency in reading technical drawings and schematics; working knowledge of GD&T.
  • Strong mechanical / electrical aptitude and understanding of machinery principles.
  • Competency in statistical analysis (Minitab preferred).
  • Skilled in Microsoft Office (Word, Excel, PowerPoint, Visio).
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