Process Engineer Level I

Diasorin • Austin, TX

4d

About The Position

The Process Engineer I will be responsible for identifying opportunities and implementing changes to improve manufacturing processes, add efficiencies, reduce costs, implement tooling and production equipment, assembly methods, quality standards, and material flow. The Process Engineer I will assist with Instrument Manufacturing processes associated with Instrument Manufacturing Production, Quality Control, and Depot.

Requirements

• Bachelor's Degree Industrial, Manufacturing, or Mechanical Engineering or related technical field with required relevant work experience.
• 5+ Years Process engineering or manufacturing experience in relevant industry with educational requirement preferred
• 2+ Years Years Process engineering or manufacturing experience in relevant industry with advanced degree requirement preferred
• 1+ Years Years Experience in a GMP and FDA regulated industry and/or a ISO certified organization preferred
• Proficient in Microsoft Word, Excel, Access, Visio and PowerPoint programs. (High proficiency)
• Thorough knowledge of cGMP regulations (High proficiency)
• Highly organized with proven time management and prioritization skills. (High proficiency)
• Ability to work independently (High proficiency)
• Ability to handle tight deadlines, frequent assignment changes, periodic heavy workload, rapidly changing technology, and dynamic business growth (High proficiency)
• Strong statistical and data analysis skills; knowledge of Statistical Process Control (SPC) and Design of Experiment (DOE) (High proficiency)
• Ability to use a systematic approach for Root Cause Analysis and knowledge of systems/processes to ensure data-driven decisions (High proficiency)
• Ability to handle multiple projects and lead positive change (High proficiency)
• Experience with time study methodologies and industrial engineering basics (High proficiency)
• Team player capable of working across functional groups to qualify new processes/ materials under a compressed schedule (High proficiency)
• Experience with LEAN Manufacturing and Six Sigma Problem solving Methodology (High proficiency)
• Ability to effectively solve complex technical problems (Medium proficiency)
• Develop in-depth knowledge across multiple business units and technical areas (Medium proficiency)
• Excellent interpersonal and oral and written communication skills (Medium proficiency)

Nice To Haves

• Mechanical design capabilities utilizing Solidworks is preferred (Medium proficiency)
• Lean Six Sigma Black Belt preferred
• ASQ Certified Quality Engineer. preferred

Responsibilities

• Participates in or leads major process improvement initiatives from identification to execution
• Identifies gaps in processes, develops project plans, and cost reduction/avoidance.
• Monitors progress and assess adequacy of output/deliverables
• Champions the understanding and application of Lean principles and techniques to maximize yield, capacity, and capability
• Creates and maintains Manufacturing Instructions, routings, and associated processes.
• Ensures effective training for new or changed processes
• Manages/Executes process validation activities for IQ (installation qualification), OQ (Operational Qualification), and PQ (Performance Qualification)
• Analyzes and maintains Value Stream Maps for ongoing processes to ensure efficient factory utilization
• Participates in infrastructure optimization and expansion
• Utilizes Lean methodology (e.g., DMAIC, Lean Manufacturing, Continuous Improvement (Kaizen), PDCA, etc.) to support the design of optimal processes
• Designs and implements layout of equipment, materials, and work cells for maximum efficiency
• Analyzes factory data and recommends projects activities to improve overall factory efficiency
• Analyzes manufacturing and field defect data, and creates and implements process improvement programs.
• Deploys standard processes and communicates cross-functional needs
• Develops best practices and standardized operating instructions to optimize processes
• Evaluates processes and equipment to ensure compliance with applicable environmental, safety and quality regulations and standards
• Monitors and reduces process variation using techniques such as Statistical Process Control (SPC), Root-Cause Analysis, Data Analytics, Scripting, Database Query Development, Product Flow Optimizations and Tableau Dashboard Development
• Participates in the development and maintenance of FMEAs and Control Plans
• Eliminates human errors by utilizing Poka Yoke
• Utilizes Line balancing, cycle time and take time to ensure customer requirements are met
• Creates ROI justifications to support process improvement initiatives
• Leads Design of Experiments (DOE) on existing and upcoming processes
• Interfaces directly with assemblers, leads, and production supervisors in resolving production problems
• Identifies automation opportunities and implements solutions
• Ability to complete hands-on tasks, up to and including actual equipment production runs
• Monitors procedural and engineering change releases; assess departmental impact
• Analyzes, develops, processs, and implements Engineering Change Orders (ECO), Manufacturer and Departmental Document change control (MCO & DCO)
• Ensures effective departmental interfaces; facilitates interdepartmental communication
• Escalates problems and potential issues through management channels as necessary
• Additional task and duties as assigned

Benefits

• Receive a competitive salary and benefits package as you grow your career at DiaSorin.
• Join our team and discover how your work can impact the lives of people all over the world.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level