The Sustaining Engineer is responsible for product development line extensions, production design changes and other engineering projects for single and multi-use medical devices. As a member of a cross-functional team, the experience needed will focus heavily on the phases of a project devoted to verification and validation activities, design transfer, through implementation.
What you will do:
- 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
- Have a significant knowledge base on production systems and manufacturing processes with an overall solid background in engineering fundamentals
- Provide innovative solutions concerning product design and development, and DFM
- Work closely with production and marketing to implement design changes to current product lines as needed.
- Using SolidWorks, develop innovative design solutions, assign realistic specifications, account for assembly tolerances within the device and work within vendor process capabilities
- Solid understanding of tolerance analysis methods.
- Proficient in understanding and writing/revising technical operating procedures for product realization and manufacturing support.
- 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
- Proficient in technical writing needed for engineering and scientific technical memos and reports.
What you need:
- Engineering Degree with 1-3 years of relevant work experience, BS in Mechanical, Biomedical, or similar Engineering Degree with 3-5 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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