Process Engineer II

Antech Diagnostics•Longmont, CO

44d•$84,000 - $105,000•Hybrid

About The Position

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. A Process Engineer II understands appropriate documentation in a regulated environment, implementing corrective actions, and experience with continuous improvement principles.

Requirements

Bachelor’s degree in engineering or related field required
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.
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.

Nice To Haves

master’s degree preferred.
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.

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.
Assists 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. Active database and data management allowing for process performance assessment via GR&R, Yield Tracking and Cpk analysis.
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.