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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