HireDiversity

San Jose, CA, US

SR. MANUFACTURING ENGINEER-5551121214

Description

Micrus Endovascular, part of Codman Neurovascular and Johnson & Johnson, is currently recruiting for a Senior Manufacturing Engineer in their San Jose, CA facility.

Micrus Endovascular develops, manufactures and markets implantable and disposable medical devices for use in the treatment of cerebral vascular diseases. Micrus products are used by interventional neuroradiologists, interventional neurologists and endovascularly trained neurosurgeons to treat both cerebral aneurysms responsible for hemorrhagic stroke and intracranial atherosclerosis, which may lead to ischemic stroke. Hemorrhagic and ischemic stroke are both significant causes of death and disability worldwide.

The Micrus product lines enable physicians to gain access to the brain in a minimally invasive manner through the vessels of the arterial system. Micrus' proprietary, three-dimensional micro coils anatomically deploy within the aneurysm, forming a scaffold that conforms to a wide diversity of aneurysm shapes and sizes. Micrus also sells stents, balloon catheters, and access devices such as guide catheters, micro catheters, guide wires and accessory products used in conjunction with its micro coils.

The Senior Manufacturing Engineer designs and develops equipment and/or processes required for new products, product changes and enhancements, as well as related tooling and fixtures, equipment and/or process refinements to improve product throughput and quality. The position executes process qualifications and validations, including equipment qualifications and material specifications where applicable, evaluates in-conjunction with EHS for new equipment, processes and chemicals use in production and creates and maintains engineering drawings in coordination with the Quality Assurance and R&D functions. The position will also coordinate and plan work of assigned technicians consistent with the corporate objectives.

The Senior Manufacturing Engineer maintains accurate documentation of concepts, designs and processes, maintains current knowledge of medical, technical and biomedical developments as related to the company products and supports prototype and pilot production and facilities and planning when appropriate. The position procures and oversee outside vendors and consultants as required, development and implementation of appropriate supporting documentation, which complies with GMP in conjunction with the other team members and is the main liaison with R&D and NPD (New Product Development) on new projects. Additional responsibilities include: assures manufacturability on new products, strives for standardization with existing components, products and processes, investigates and/or suggests less labor-intensive options to team and investigates of-the-shelf or easily modified tooling that can assist manufacturing from day one.

The Senior Manufacturing Engineer determines, with production, standard labor run rates on new products, develops solutions to production problems relating to materials, processes and tooling, develops and implements alternate materials, delivery, and assembly techniques that will provide cost savings and works in conjunction with Process Development to transfer process and test methods from R&D through validations into production group. The position prepares all manufacturing related documents needed for ECO (Engineering Change Order), is active in overall engineering of the product, involves other groups (i.e. Production, QA, Materials/Planning Group, ME Techs, etc.) as needed and coordinates production resources as needed. The Senior Manufacturing Engineer communicates forecasts and build needs (on new products) to affected groups as soon as available, works with QA and Materials/Planning Group to introduce, visit, and qualify new suppliers, intimately oversees first production runs and participates in cost studies, equipment recommendation and justifications. The position may have direct reports of Engineers, technicians and assembly personnel. The position is located in San Jose, CA and requires up to 5% domestic travel.

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Qualifications


It is required the Senior Manufacturing Engineer have an understanding of electrical and pneumatic schematic diagrams, be strong in small part fixture design, familiar with DOE and statistical techniques and knowledgeable in defining process capabilities and control charting. It is required the successful candidate possess experience writing of protocols for validations and qualifications, working knowledge of machine shop tools and equipment and proficiency with CAD software. It is preferred the Senior Manufacturing Engineer be proficient in the use of controllers and their programming (PLC's) and SolidWorks.

It is required the Senior Manufacturing possess a BSME degree or related engineering discipline. It is required to possess a minimum or 5 years related experience with a Bachelor's degree or a minimum of 3 years related experience with a MS degree. It is required to possess the ability to perform other activities in support of administration, product development, manufacturing, and release, as directed by Senior Management. It is required to possess the ability to sit, stand, walk, talk and hear and specific vision abilities include close vision and the ability to adjust focus in a lab environment. The position may be required to have the ability to solely lift items totally 30 pounds or less. Medical device and regulated work industry experience is preferred. The position is located in San Jose, CA and requires up to 5% domestic travel.

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Primary Location:North America-United States-California-San Jose
Organization: Micrus Endovascular (6208)