Senior Manufacturing Engineer

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  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.
  

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  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.
  

Position Summary

The Manufacturing Engineering team is responsible for the innovation of new production systems as well as the industrialization and sustainment of such systems. Sr. Engineer is responsible to apply engineering principles to create practical solutions to technical challenges and provide technical support across functions with minimal supervision. Apply skills in the areas of equipment designs, process scale-up from R&;D, process improvement of existing processes and implementation of automated control systems. Also plan, coordinate and drive all necessary activities to validate manufacturing facilities, equipment and processes. evaluate and optimize processes to improve product consistency and to increase productivity. Support company goals and objectives, policies and procedures and FDA regulations. Assist in the development and performance of validations on equipment. Support applicable regulations including ISO13485, Local, State, and/or Federal requirements.

Key Duties and Responsibilities

• Plan and execute the implementation, and successful scale-up of automated and semi-automated solutions based upon sound engineering principles
• Lead improvement initiatives to improve production processes to increase productivity, manufacturing yields, reduce production costs and decrease or eliminate scrap.
• Initiate protocol, execute and write final report for validation of equipment and processes (IQ/OQ/PQ).
• Design and develop new manufacturing processes, sequence of operations, procedures and production layouts for assemblies, equipment installation, processing and material handling based on product design requirements.
• Design tooling and fixtures as needed in order to enhance productivity and product quality.
• Writes clear and detailed manufacturing SOPs, URS, Engineering reports, ECRs, and other technical documents.
• Perform capacity, equipment efficiency, and labor utilization analysis to optimize manufacturing processes.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Troubleshoot manufacturing process and equipment; provide manufacturing engineering support to resolve production issues.
• Work with R&D and other cross functional teams to successfully transfer new products into production and ensure that design for manufacturability principles are applied to new processes.
• Interact and coordinate activities such as CAPA investigations, and NCRs with Production and QC/QA personnel.
• Ensures processes and procedures are in compliance with GMP and GAMP regulations.
• Leads manufacturing engineering project plans by utilizing project management skillsets that include creating timelines.
• Perform other related duties as required or assigned.

Education, Experience, and Qualifications

• Bachelor's Degree in an engineering discipline such as Bio-Medical, Mechanical, Material or Industrial Engineering required

• 5+ Years related experience in IVD, medical, pharmaceutical, or other related industry required
• Extensive experience in equipment and process validation in Medical device or pharmaceutical industries required
• Process automation experience preferred

Training and Skills

• Thorough understanding of statistical quality control, statistical process control, corrective action process, and their application manufacturing as a problem identification and resolution tool
• Proficient in Advanced SPC, Quality Analysis Tools (Taguchi, Fishbone), FMEAs & DOE
• Demonstrated experience in application of LEAN manufacturing principles.
• Strong computer skills in Microsoft Office applications, Solidworks and Minitab. Familiarity with Google Suite is a plus.
• Ability to write reports, business correspondence, and effectively present information
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

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.