Manufacturing Technician III

Endogenex is a privately held, clinical-stage company based in Plymouth, MN, dedicated to transforming treatment options for individuals with type 2 diabetes (T2D). In partnership with Mayo Clinic, Endogenex focuses on resetting the body’s metabolic signaling system by leveraging its natural regenerative capabilities to improve metabolic function. The company is developing the Endogenex System, which uses precise, controlled, non-thermal pulsed electric fields to establish a new era in T2D treatment. These innovations aim to help people living with T2D regain control of blood glucose levels and slow disease progression, offering meaningful advances in patient care. Role Description The Manufacturing Technician III is a full-time, on-site role located in Plymouth, MN. This role is responsible for performing hands-on assembly and testing activities in support of a medical device manufacturing line. This position executes established manufacturing processes with a high degree of accuracy and consistency, supports process and equipment troubleshooting, and helps maintain compliant, efficient production. This role requires solid hands-on manufacturing skills, attention to detail, and the ability to follow documented procedures within a regulated environment. Daily Responsibilities Include Perform setup, operation, and routine troubleshooting of manufacturing processes, fixtures, and equipment under the guidance of Senior Technicians and Engineers. Assist with line startup activities and flag potential issues or improvement opportunities to Manufacturing Engineering. Provide hands-on support to Manufacturing Engineering during fixture and equipment installation and setup. Support process characterization and validation activities, including data collection, analysis, and documentation. Manufacture clinical and commercial medical device products in accordance with approved procedures and quality system requirements. Develop working knowledge of assigned manufacturing processes and serve as a reliable resource for day-to-day production questions. Assist Senior Technicians and Manufacturing Engineering with the training of new operators and technicians as needed. Ensure all manufacturing activities are performed in compliance with ISO 13485, FDA Quality Management System Regulations (21 CFR 820), and internal procedures. Support investigations of nonconformances related to manufacturing processes. Utilize measurement tools and inspection equipment to collect data and support process monitoring and improvement efforts. Respond to and resolve line-down events with a sense of urgency Perform minor equipment maintenance as needed Qualifications High School diploma or equivalent Associate’s degree, technical certification, or equivalent combination of education and experience. (preferred) 2-4 years of experience in hands-on manufacturing or assembly within a highly regulated industry (medical device strongly preferred) Hands-on experience with fine-detail assembly processes such as soldering small components, UV bonding, heat sealing, and reflow (preferred) Demonstrated ability to consistently produce high-quality work while following detailed procedures Ability to read/interpret manufacturing procedures and other technical documentation Ability to work in an onsite, cleanroom manufacturing environment Introductory knowledge of statistical tools and improvement techniques (SPC, DOE, Lean/Six Sigma) preferred Strong communication skills with the ability to work effectively in a fast-paced, collaborative environment

SPECIAL PHYSICAL DEMANDS AND WORKING CONDITIONS

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally required to walk; sit; use hands to finger, handle or feel objects, tools, or controls; reach with hands and arms; balance; stoop; talk and hear. Specific vision abilities required by the job include close vision and distance vision. Ability to occasionally lift and/or move up to 35 pounds. 2)Work environment: Will work in an ISO class 8 cleanroom manufacturing environment with gowning requirements. While performing the duties of this job, the employee will experience in/out of the office noise at a minimal level. Must be capable of transporting self to various business locations infrequently. If you use your own motor vehicle, you must have a current, valid state driver’s license and proof of insurance coverage that at least meets current residence’s state minimum requirements.

ADDITIONAL NOTES

Endogenex is an Equal Opportunity Employer. Please note this job description is not intended to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this position. Responsibilities, duties, and activities may change at any time with or without notice. The above statements are intended to describe the general nature and level of work being performed, and do not serve as an employment contract, nor alter the at-will employment status. #J-18808-Ljbffr Endogenex