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About the Role

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.

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

Requirements

Bachelor's Degree Industrial, Manufacturing, or Mechanical Engineering or related technical field with required relevant work experience.
2+ 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)
Mechanical design capabilities utilizing Solidworks is preferred (Medium proficiency)

Skills

Lean principles
Lean methodology (DMAIC, Lean Manufacturing, Continuous Improvement (Kaizen), PDCA)
Statistical Process Control (SPC)
Root-Cause Analysis
Data Analytics
Scripting
Database Query Development
Product Flow Optimizations
Tableau Dashboard Development
FMEAs
Control Plans
Poka Yoke
Line balancing
Cycle time
Take time
Design of Experiments (DOE)
Time study methodologies
Industrial engineering basics
LEAN Manufacturing
Six Sigma Problem solving Methodology
Microsoft Word
Microsoft Excel
Microsoft Access
Microsoft Visio
Microsoft PowerPoint
cGMP regulations
Solidworks

Experience Level

2+ Years Process engineering or manufacturing experience
1+ Years Experience in a GMP and FDA regulated industry and/or a ISO certified organization

Education Level

Bachelor's Degree Industrial, Manufacturing, or Mechanical Engineering or related technical field

Benefits

Competitive salary and benefits package

About the Company

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide.
With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.
Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."
When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.
Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.
If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.
Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

Equal Opportunity

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.
Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.