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™. Koru is expanding beyond its core franchise in Immunoglobulin therapy to partner with biopharma companies for the ~750 drugs being developed for subcutaneous infusion. The Company maintains its corporate headquarters and manufacturing facility in Mahwah, New Jersey.  For more information about the Company, please visit www.korumedical.com.

As a Staff Mechanical Engineer, you will provide technical leadership and individual contributions to mechanical and electro-mechanical engineering design and development efforts on multi-disciplinary project teams to create reliable, robust, high performance medical instrumentation, components, and consumables. Applies advanced technical insight, judgment, and problem-solving skills to technology assessment, innovation, and product development from concept to product launch. Guides technical teams to most effective manufacturing solutions and design.

What you will do:

• Works with program managers to establish schedules and resource requirements for device, and consumables development.
• Develops design input (specifications) for the consumables and mechanical systems.
• Prepare cost estimates and designs products to meet cost targets.
• Leads or participates in design reviews. Thoroughly assesses the ability of proposed designs to meet specified requirements, including manufacturability.
• Generates engineering drawings and specifications to division standards, including ASME Y14.5M-2009 Dimensioning and Tolerancing.
• Conforms to the requirements of ISO and cGMP standards for the design and development of medical devices.
• Independently plan, implement, monitor, and deliver designated tasks and deliverables to achieve project driven objectives for New Product Development.
• Provide technical support to regulatory submissions and product transfers
• Support current products in terms of quality, manufacturing, supply continuity and cost improvement
• Take product from concept through to production with a practical understanding of manufacturing and solid engineering fundamentals
• Provide innovative solutions concerning product design and development, and DFM
• Utilize pilot production methods and materials together with DOE and FMEA for proof of concept
• Using SolidWorks, develop innovative designs, assign realistic specifications, account for assembly tolerances within the device and work within vendor process capabilities
• Work seamlessly within multi-user SolidWorks environment for file sharing and revision control
• Lead activities related to test and evaluation of prototypes and finished medical devices
• Coordinate internal and external design program resources as well as vendors
• Ensure compliance with quality policies, procedures and practices as well as with all local, state, federal, international and company safety regulations, policies and procedures

What we are looking for

• Bachelor's Degree in Mechanical Engineering or Biomedical Engineering required with a minimum of 8 years engineering experience required or equivalent combination of industry experience and advanced education.
• Five years’ experience with solid modeling CAD applications of components with complex geometries. SolidWorks and Simulation experience preferred. Applied usage of Geometric Dimensioning and Tolerancing (GD&T) preferred
• Pharmaceutical and/or medical device industry experience, with a strong record of delivering products to market or developing commercially viable technology is desired.
• Strong technical judgment and advanced technical leadership skills.
• Experienced in phase gate product development processes and project planning tools
• Experience, and demonstrated proficiency, in the design of high-quality disposable and reusable medical devices
• Expertise in Design for Assembly and Design for Manufacturability
• Experience in plastic materials and injection molding techniques
• Knowledge of medical device sterilization methods and its effect on materials and packaging methods
• Demonstrated experience or knowledge with all phases of the Design Control and Validation processes in the context of FDA and ISO 13485 regulations and understanding of disciplined product development processes, regulatory and quality requirements for medical products
• A clear understanding of manufacturing process validation including FAI/FAT, development, and IQ/OQ/PQ, with experience in the implementation of these activities 

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.