Senior Manufacturing Engineer

System One; Orangeburg (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading engineering services company seeks a Senior Manufacturing Engineer to address complex production challenges and ensure process quality in the medical device sector. The role involves technical leadership, project management, and collaboration with R&D and suppliers to enhance manufacturability and product robustness.

Qualifications

• 10+ years of experience in IVD Diagnostic Medical Device or Pharmaceutical.
• Strong engineering background in Chemical or Mechanical disciplines.

Responsibilities

• Responsible for production process issue resolution and leading remediation efforts.
• Leads process engineering support activities and continuous improvement initiatives.
• Writes technical documentation including process procedures and validation plans.

Skills

Problem Solving

Process Improvement

Technical Leadership

Education

Chemical Engineering Degree

Mechanical Engineering Degree

Job description

Title Senior Manufacturing Engineer
Hours: 8:00am-4:30pm
Onsite: 100% onsite
Duration: 1+ year contract
Location: Orangeburg NY


Requirements:

• 10+ years of experience in IVD Diagnostic Medical Device or Pharmaceutical Exp.
• Chemical Engineering or Mechanical Engineering Degree

Responsibilities:

• Responsible for the resolution of production process issues utilizing problem solving techniques to analyze, identify root cause(s), develop and implement solutions. (lead Remediation Efforts)
• May be required to act as Product Champion for a specific product or product line with the following leadership responsibilities: The focal point in operations for the products which they have responsibility for.
• Leads the resolution of production process issues utilizing problem solving techniques to analyze, identify root cause(s), develop and implement solutions.
• Leads the process engineering and production support activities required for the manufacture of a product line.
• Provides technical support and leadership for continuous improvement team efforts focused on process improvement and improvements to product manufacturability. (Lead on Projects)
• Provides technical leadership and hands-on engineering support, including specification and implementation of assembly/test methods and process optimization.
• Provides technical support for continuous improvement efforts conducting root cause analysis then formulating and implementing corrective action proposals.
• Responsible for establishing the Manufacturing Quality Plan (MQP) for a product or product line including process flow, production floor layout, equipment, line balancing, etc.
• Writes process procedures, change orders, equipment specifications, validation plans, and reports.
• Performs research on technology, equipment and tooling to improve process quality, yield or cost; Generates proposals for purchase and implementation, including cost of ownership, ROI and benefit analysis.
• Performs engineering design of test equipment, assembly equipment, fixtures and tools; Performs IQ/OQ/PQ validation activities.
• Participates in the introduction of new products into manufacturing; Collaborate with R&D and suppliers to improve product robustness and manufacturability both pre- and post-release.
• Supervises (as assigned) personnel in classifications below that of Senior Mfg. Engineer.
• May lead or participate in Lean Six Sigma projects of significant scope and complexity

Ref: #558-Scientific