Process Engineer II

Job Purpose/Overview

A Process Engineer II is required to maintain day-to-day operations in manufacturing, maintaining and improving upon existing equipment as well as ensuring product quality and yield. A Process Engineer II works closely with other teams and under the guidance of their manager to transfer and develop new products and processes.

Essential Duties And Responsibilities

• Lead efforts to provide sustaining support to operations utilizing continuous improvement principles and technical support to operations utilizing root cause analysis to implement corrective actions.
• Enables company growth by ensuring on-time equipment milestone deliveries.
• Recommends and implements equipment and process modifications to improve production efficiencies, manufacturing techniques and production yields for existing products.
• Aids in developing high-level capital equipment integration protocols and procedures for manufacturing.
• Develops and conducts statistical analysis such as Design of Experiments (DOE) and Statistical Process Control (SPC) targeting physical cause of failure for yield loss and improving quality.
• Accurately documents all work products to ensure equipment qualifications and in line with and follow IQ, OQ, PQ requirements.
• Interacts with design staff to ensure that processes and designs are compatible with existing equipment.
• Translate design requirements into production by defining, designing and/or communicating efficient and capable process tooling.
• Utilizing GDP, author documents including but not limited to manufacturing Standard Operating Procedures (SOPs), and detailed work instructions.
• Trains manufacturing staff on proper processes to follow when operating equipment, including wave-guide instrument(s).
• Ensures that team and staff members follow safety rules and protocol.
• Other duties as assigned.

Education And Experience

• Bachelor’s degree in engineering or related field required; master’s degree preferred.
• Five to seven (5-7) years prior experience in an R&D or production environment with proven success of process improvement and scale-up projects.
• Experience in a regulated environment (FDA, ISO, etc.), preferred.
• Experience in project management preferred.
• Experience in the medical device field, specifically invitro diagnostics, preferred.
• Licenses or certifications such as ISO, PMP, LEAN, IFMA, MPS, Six Sigma, cGMP, preferred.

Knowledge, Skills And Abilities

• Excellent written and verbal communication skills; able to communicate technical information to technical and non-technical staff to ensure understanding.
• Excellent problem-solving skills and demonstrated ability to collaborate in problem solving.
• Excellent data gathering and analysis skills.
• Excellent electro-mechanical equipment development and troubleshooting skills.
• Knowledge of QMS, including experience with deviation, CAPA, and other quality related objectives and requirements.
• Software use and knowledge: Windows, MS Office products, SolidWorks (or similar).
• Able to develop effective partnerships across the organization and to serve as a liaison between R&D and Manufacturing.
• Self-starter, with ability to work on own initiative.
• Highly organized and able to balance multiple demands and priorities.