Senior Manufacturing Engineer Job at Diasorin (Stillwater, Minnesota)

Senior Manufacturing Engineer

Diasorin

Location:
United States , Stillwater, Minnesota

Category:
Manufacturing

Contract Type:
Not provided

Salary:

112000.00 - 149000.00 USD / Year

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Job Description:

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.

Job Responsibility:

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

Requirements:

Bachelor's Degree in an engineering discipline such as Bio-Medical, Mechanical, Material or Industrial Engineering required
6+ Years with BS and 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
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
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

Nice to have:

Master's Degree or PhD in an engineering discipline such as Bio-Medical, Mechanical, Material or Industrial Engineering preferred
Process automation experience preferred
Familiarity with Google Suite is a plus

What we offer:

comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks
eligible to participate in an annual incentive program

Additional Information:

Job Posted:
April 11, 2026

Employment Type:

Fulltime

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