HireDiversity

Irwindale, CA, US

SENIOR, MANUFACTURING ENGINEER-6586120109

Description

Biosense Webster, Inc., is recognized worldwide as an industry leader in endocardial diagnostics and therapy. Guided by the needs of electrophysiologists and cardiologists, the company has pioneered innovative technological advancements ranging from the first deflectable tip catheter to today's most sophisticated three-dimensional cardiac mapping and navigation systems. Biosense Webster, Inc., combines leading-edge technology with a tradition of quality and responsiveness while partnering with the physician to optimize patient outcomes.

Summary of the Job:

Under little or no supervision provides a lead role in transfer to manufacturing, test, validate process and development of production tooling to support the manufacture of medical devices for the renal business sector.

Essential Duties and Responsibilities:

Under (e.g. limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

Leads and provides guidance in the development of manufacturing processes, validation units and product specifications, including material specifications, assembly drawings, tooling and manufacturing documentation

Develops concepts, designs and details for to support the manufacturing of new products. .

Provides documentation of all design changes needed to facilitate manufacturing.

Supports the creation of the test plan, device limitations and their acceptance criteria.

Responsible for the timely completion of the manufacturing/technical deliverables.

Provide sustaining engineering and support of products after manufacturing transfer.

Interfaces with outside business partners as needed.

Draws preliminary sketches and prepares layout and detail drawings for manufacturing tooling.

Create Intellectual Property through idea and product submissions and patent applications.

Mentor technicians and less experienced engineers.

Travel to observe procedures, attend sponsored meetings and meet with customers, business partners or suppliers.

Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.

Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new products

Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.

Responsible for communicating business related issues or opportunities to next management level

Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition

Performs other duties assigned as needed

Qualifications


Education/Training and/or Experience:

BS with 5-8 years of related experience; or MS with 4-6 years of related experience. Experience in manufacturing transfer required. Process validation and design/creation of tooling is highly preferred.

Knowledge, Skills, Abilities and Certifications/Licenses:

Ability to use PC and associated software. Ability to use various Auto-CAD software systems. Knowledge of purchasing systems. Knowledge of GMP and other regulatory requirements. Complete understanding and wide application of technical principals, theories and concepts in the field. General knowledge of other related disciplines. Thorough understanding of project management. In-depth knowledge of materials and metals. Able to lead, work and communicate effectively with other engineers, designers, surgeons, marketers and suppliers to develop products from concept through commercialization in a cross-functional team. Strong problem solving and analytical skills. Effective oral, written communication and presentation skills. Exercises good judgment when communicating to all levels in the business organization. Must be able to handle multiple tasks/projects and manage project closure

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-California-Irwindale
Organization: Biosense Webster Inc. (6010)