Engineering - Manufacturing Engineer III

Engineering - Manufacturing Engineer III

JOB SUMMARY:

Manufacturing Engineer leads initiatives for the daily support of production lines, manufacturing processes, materials, and equipment to meet the performance goals (i.e., safety, quality, cost, and delivery). The primary of this role involves the plastics injection molding and assembly process. The expectation with this role is to have a high level of interaction with the customers and suppliers. Will spend time with the operators as well with counterparts in other technical functions (i.e. Quality, Production Supervisors, and Equipment Techs). Works with operational excellence to support implementation and control of value added activities. Will work in a fast-paced and dynamic environment; this position will be responsible for several manufacturing processes, working cross-functionally with quality and production teams to achieve goals.

RESPONSIBILITIES:

• Provides support of production, processes, materials and equipment to achieve department goals (i.e. safety, quality, delivery, and cost).
• Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing on complex projects to ensure project success.
• Successfully completes complex engineering work and contributes to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, Six Sigma, process study, process improvements, and report preparation.
• Performs equipment qualification, process validation, and test method validation activities
• Prepares engineering reports and communicates results to the technical and leadership audiences.
• Perform DOE processing runs to support FDA process validation procedures.
• Designs and coordinates applicable engineering tests and experiments.
• Performs troubleshooting on new and existing products/process problems as related to design, material, or processes.
• Summarizes, analyzes, and draws conclusions from complex test results.
• Applies problem solving and process improvement methodologies to improve complex and diverse manufacturing processes across multiple product lines, ensuring root cause of problem is identified and quickly resolved.
• Prepares standard reports/documents to communicate results to the technical community.
• May lead cross-functional project teams.
• Will perform “gemba” walks to audit machine and operator related processes.
• Works with operational excellence to support implementation and control of value added activities.
• Will support on NPI transition to production environment.
• Identifies, implements, and manages equipment requirements to support production goals.
• Trains and/or provides work direction to operators/technicians.
• Will support on any given task related to manufacturing process and/or equipment.

POSITION REQUIREMENTS:

• Bachelor’s degree in Engineering-related discipline
• 1- 4 years in medical device or equivalent.  0 - 2 years' of experience in a manufacturing environment with injection molding or extrusion processes or a plastics engineering degree.
• Demonstrated interpersonal skills with ability to work within a team environment.
• Training experience to FDA regulations or ISO standards
• Preferred qualifications: Six Sigma problem-solving methodologies.
• Ability to manage multiple projects and responsibilities simultaneously.
• Ability to effectively troubleshoot manufacturing processes.
• Highly collaborative, with strong written and verbal communication skills.
• Familiar with Process Improvement and Problem Solving tools such as Plan, Do, Check, Act.
• Knowledgeable of statistical tools for evaluating process performance, measuring relationships between variables and cause-effect analysis.

LEADERSHIP RESPONSIBILITY:

Leads and/or influence operators and Quality Inspectors

OTHER:

The role is required to be 100% onsite with occasional travel as deemed necessary.