The Senior Product Development Engineer is responsible for product development, production design changes and other engineering projects for single and multi-use medical devices. As a member of a cross-functional team, this experience will span the entire development process, from concept development to reliable implementation.
Essential Job Functions:
- 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
- BS in Mechanical, Biomedical, or similar Engineering Degree with 5-7 years of relevant work experience.
- Project management experience
- Experience, and demonstrated proficiency, in the design of high-quality disposable and reusable medical devices
- Proficient in SolidWorks or other CAD package (SolidWorks strongly preferred)
- 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
- Ability to work independently as well as in a team-oriented environment
- Candidates should also be creative, inquisitive, analytical, and detail oriented
- Effective communication skills (both orally and in writing) are required
- Strong technical judgment and problem-solving skills are essential
- Experience in 3D printing a plus
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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