J&J Family of Companies Manufacturing Engineer II in San Jose, California
Codman Neuro, part of DePuy Synthes and Johnson & Johnson, is currently recruiting for a Manufacturing Engineer II in their San Jose, CA facility.
Codman Neuro develops a wide range of diagnostic and therapeutic products for the treatment of neurovascular and neurological disorders, focusing on hydrocephalus, neuro-critical care, tumors, pain management, severe spasticity, aneurysms and cerebral arteriovenous malformations. This division focuses on minimally invasive solutions for hemorrhagic and ischemic strokes, and treatment of treatment of cerebral arteriovenous malformations. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Manufacturing Engineer II will:
Design and develop equipment and/or processes required for new products, product changes and enhancements, as well as related tooling and fixtures, the equipment and/or process refinements are to improve product throughput and quality.
This individual will perform process qualifications and validations, including equipment qualifications and material specifications where applicable.
S/he will create and maintain engineering drawings in coordination with the Quality Assurance and R&D functions.
S/he will coordinate and plan work of assigned technicians consistent with the corporate objectives.
S/he will maintain accurate documentation of concepts, designs and processes, current knowledge of medical, technical and biomedical developments as related to the company products.
This individual will support prototype and pilot production and facilities engineering and planning when appropriate. S/he will procure and oversee outside vendors and consultants as required.
This person will maintain and comply with ISO & FDA regulations.
Assures manufacturability of current and new products.
This person will strive for standardization with existing components, products and processes.
S/he will investigate of-the-shelf or easily modified tooling that can assist and improve the manufacturing process.
S/he will determine, with production, standard labor run rates on new products.
S/he will develop solutions to production problems relating to materials, processes and tooling and develop and implement alternate materials, delivery, and assembly techniques that will provide product quality improvements and cost savings.
S/he will work in conjunction with New Product Development group to transfer process and test methods from R&D through validations into production group.
This individual will prepare all manufacturing related documents needed for release.
This person is active in overall engineering of the product and involves other groups (i.e. materials, equipment engineering, ME Techs, production, etc.) as needed.
S/he will coordinate production resources as needed.
This person will work with QA and materials to introduce, visit, and qualify new suppliers. S/he will participate in cost studies, equipment recommendation, and justifications.
A minimum of BS degree is required.
A focus degree in mechanical engineer or related engineering discipline is preferred.
2+ years of experience in the medical device industry or in a highly regulated, compliance-oriented and standards-driven environment is required.
An understanding of electrical and pneumatic schematic diagrams is preferred.
Proficiency in small part fixture design is preferred. Ability to write protocols for validations and qualifications is required.
Proficient in the use of controllers and their programming (PLC’s) is preferred.
Knowledgeable in defining process capabilities and control charting is required.
Familiarity with DOE and statistical techniques is required.
Proficiency with CAD software required, SolidWorks is preferred. Working knowledge of machine shop tools and equipment is preferred.
Strong communication skills, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to effectively present information and respond to questions from groups of managers, clients and customers.
Ability to write reports, business correspondence, and procedure manuals required.
This position is located in San Jose, CA and may require travel up to 10%.
United States-California-San Jose
DePuySynthes Products Inc (6149)