KORU Medical Systems is a leading developer and manufacturer of medical devices that help patients have the best possible experience subcutaneously infusing biologic medications at home. KORU’s primary line is the FREEDOM Syringe Infusion System, including the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HIgH-Flo Subcutaneous Safety Needle Sets™. The Company maintains its corporate headquarters and manufacturing facility in Chester, New York. For more information about the Company, please visit www.korumedical.com.
An engineer that will operate as a conduit between the manufacturing and product development teams, ensuring that activities needed to ensure a proper design transfer process have been completed successfully and according to Koru Medicals standard operating procedures.
Essential Job Functions:
- You will use engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
- You will provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Koru Medical new product development procedures.
- You will ensure quality of process and product as defined in the appropriate operation and material specifications.
- You will assist in the selection of equipment based on analysis of specifications, reliability, and regulatory requirements.
- You will support capital acquisition activity from specifying equipment, installation, and validation.
- You will analyze equipment to establish operating data, conduct experimental test and result analysis. Lead and/or participate in process review meetings.
- You will design manufacturing assembly and inspection tools and fixtures as needed to support product development activities.
- You will participate in process failure mode and effect analysis (PFMEA), control plan, standard operating procedures (SOP) and production part approval process (PPAP) generation associated with product transfers and launches.
- You will complete capability studies for in process inspection and generate subsequent Inspection documentation.
- You will conduct process validation and MSA studies for new products and new processes.
- You will drive and execute effective communication with all stakeholders to enable project success.
- You will work in a hands-on manner at the manufacturing site to support the implementation of new processes.
- You will review and approval of validation documentation.
- You will provide training for manufacturing team members.
- Bachelor’s degree in engineering, preferably Mechanical Engineering - required
- Basic knowledge of manufacturing processes, materials, product, and process design - required
- 2+ years’ work experience - required
- Writing & Executing Validations experience – preferred
- Ability to read and interpret complex engineering drawings & understand geometrical dimensioning and tolerancing – required
- Lean Six Sigma Green Belt Certification or above - preferred
- Writing & Executing Validations experience - preferred
- New Product Introduction & Advanced Manufacturing Engineering experience – preferred
- Medical Device or regulated experience - preferred
DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Therefore, employees assigned may be required to perform additional job tasks required by the manager.
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
KORU Medical Systems provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, marital status, pregnancy, parental status, national origin, ethnic background, age, disability, political opinion, social status, veteran status, union membership or genetics.
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