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Staff (IV) New Product Introduction, Neurovascular
Requisition ID: 9039180111
Cerenovus, part of the Johnson and Johnson Medical Devices Companies is recruiting for a Staff (IV) New Product Introduction Engineer, Neurovascular, located in Miami, FL.
CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.
Our implants and instruments are used by neurovascular specialists to diagnose and treat a wide range of disorders focusing on aneurysms, stroke and cerebral arteriovenous malformations. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding.
The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular, Surgical and Non-Surgical Aesthetics, and Reprocessing.
- The Staff (IV) New Product Introduction Engineer, neurovascular position works within multi-functional project teams including R&D, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to develop innovative new products for the neurovascular medical device industry.
- This position works as a recognized manufacturing and process technical authority who can provide process engineering knowledge and oversight particularly in the areas of process development for NPD products
- Designs, specifies, develops, and procures new manufacturing tooling, fixtures and equipment. manages the implementation and validation of new manufacturing processes and equipment to support the assembly of new neurovascular products.
- You will support the selection and validation of new materials, such as polymers, metals, and adhesives, for neurovascular applications.
- This position works closely with R&D engineering during early product development activities to provide integrated Design for Manufacturing support and advice to NPD development programs.
- Provides financial cost evaluations and labor assembly estimates for new products. Writes assembly procedures and work instructions for manufacturing of new products, and provides the training and guidance to implement such procedures.
- You will demonstrate solid hands-on engineering skills in the development of new processes.
- Identifies and provides creative new manufacturing technologies from current industry standard methodologies that can be applied to neurovascular products.
- You will represent Franchise Operations on strategic new projects including breakthrough manufacturing technologies.
- A minimum of a BS Engineering degree in Mechanical, Materials or Biomedical Engineering with a minimum of 8 years relevant engineering experience or MS Engineering degree with 6 years of relevant engineering experience is required for this role.
- Prior experience in developing new processes is required.
- Experience working in highly regulated industry is required; Medical device industry is preferred.
- Familiarity with ISO 13485 Design Control, and manufacturing process IQ, OQ, PQ qualifications as related to medical devices is required.
- Six Sigma Process Excellence knowledge is required with certification at the Black belt level preferred.
- Experience in some special processes such as polymer processing (compounding, extrusion, fusing), metal processing (machining, laser cutting, polishing), welding, coil winding, equipment & tool design is required. Nitinol experience desired
- Process automation knowledge for small scale assembly is preferred. Knowledge of Design for Manufacturability in plastics, metals and small-scale assembly processes is required.
- Knowledge of financial accounting and analysis methods to assess product standard costs, project values, and capital requirements is required.
- Leadership experience in leading technical relationships with external suppliers and OEMs is required.
- Strong communication, team building, and multi-functional coordination skills is required.
- Ability to travel up to 10% domestically is required.
- This position is based in Miami, FL
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