The Project Engineer will use expert technical skills to conceive, plan and lead R&D product development activities to achieve project goals. You will leverage understanding of advance engineering principals, advanced engineering methods, data, and judgement to influence the course of product development activities.
Essential Job Functions:
- Lead technical efforts for the design and product lifecycle of drug delivery medical devices in a FDA and ISO regulated environment
- Decompose project needs and goals into clearly defined deliverables, activities, work tasks, and action items.
- Responsible for designing and developing a product/product family.
- Applying technical expertise in mechanisms, fluidics, and electronics to lead efforts in test method development, implementation, and validation for medical device/systems.
- Ensures production procedures efficiently utilize materials and personnel.
- Tests finished product for quality purposes and recommends changes to product specifications, as necessary.
- Assessing design feasibility and testing product functionality and/or confirm product capabilities
- Participating in the evaluation and assessment of competitive products, processes, and/or new trends
- Developing system modules to facilitate decisions concerning system architecture, system requirements, design tolerance allocation and risk management
- Bachelor’s Degree in engineering, required.
- Master’s degree in engineering, strongly preferred
- 10 years experience as a product development engineer including 5 years of medical device experience
- Demonstrated experience with product development lifecycles
- Experience with drug delivery and / or infusion devices strongly preferred
- Demonstrated experience with Solidworks; other MCAD tools will be considered
- Strong experience with design transfers functions, system modeling and simulation, and risk management.
- Experience with ISO requirements and GMP guidelines, FDA regulations, design control.
- Proven ability to deliver results under tight deadlines
- Excellent analytical, problem-solving, and critical thinking skills
- Ability to lead, influence and communicate with diverse cross-functional teams
- Excellent writing, presentation skills; strength in Excel and PowerPoint
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.
Please fill out the form below to submit your application.