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The Process Engineer I is responsible for identifying and implementing manufacturing process improvements to enhance efficiency, reduce costs, and ensure quality standards. They will manage process validation activities, maintain manufacturing documentation, and lead cross-functional initiatives to optimize factory utilization.
Requirements
Candidates must hold a Bachelor's degree in Industrial, Manufacturing, or Mechanical Engineering with at least 2 years of relevant industry experience. Proficiency in cGMP regulations, statistical analysis, and Lean manufacturing methodologies is required.
Full job description
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."
Why Join Diasorin?
Impactful Work: 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.
Global Reach & Innovation: 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.
Diverse and Inclusive Culture: 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.
Join Our Team: 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!
Job Scope
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.
Key Duties and 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
Education, Experience, and Qualifications
Bachelor's Degree Industrial, Manufacturing, or Mechanical Engineering or related technical field with required relevant work experience. required
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)
Lean Six Sigma Black Belt preferred
ASQ Certified Quality Engineer. preferred
What we offer
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.
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 [email protected] or 1-800-328-1482 to request an accommodation.
The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.
Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.
Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.
This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.
Related keywords
Process EngineerManufacturingLeanSix SigmaGMPFDAISOSPCDOEFMEAPoka YokeECOTableauSolidworksRoot-Cause AnalysisValue Stream Mapping
Headquartered in Italy and listed on the Italian Stock Exchange within the FTSE MIB Index, Diasorin is a global leader in the In Vitro Diagnostic (IVD) field and, since 2021, has been active in the Life Science business. For over 50 years, the Company has been developing, producing, and marketing reagent kits used by diagnostic laboratories worldwide.
The Group operates across five continents through 35 companies, 4 branches, 10 manufacturing facilities, and 9 research and development centers. Our extensive diagnostic testing and life science offering, continuously enhanced through significant investments in research, positions Diasorin as the player with the broadest range of specialty tests available in the diagnostic market, identifying the Group as “The Diagnostic Specialist.”
With a team of over 3,200 employees worldwide, including more than 400 researchers, we are committed to improving healthcare and enhancing people's quality of life. We value diversity, skills, and talent as key drivers of innovation and excellence, fostering an inclusive work environment that evolves alongside the ever-changing landscape of global healthcare.
Offices: Via Crescentino, Saluggia, VC 13040, IT · 11331 Valley View St, Cypress, California, California 90630-4717, US · 1951 Northwestern Avenue PO BOX 285, Stillwater, Minnesota 55082 - 0285, US · 12212 Technology Blvd, Austin, Texas 78727, US
Based on 6625 listings with disclosed salaries, most engineering jobs in Texas pay between $83k–$203k per year. Individual offers vary with seniority, company size, and specialization.
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