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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Senior Manufacturing Engineer • Mansfield, MA, United States
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