Sr. Principal Manufacturing Technician

Johnson & Johnson Medical Devices Companies a member of Johnson & Johnson's Family of Companies is recruiting for a Senior Principal Manufacturing Technician. This position will be in Santa Clara, California.

The Senior Principal Manufacturing Technician performs complex or specialized technical assignments usually in the nature of projects, which requires the ability to work independently. May design, develop, maintain or modify manufacturing equipment, materials, systems and products. Uses considerable judgment, a high degree of initiative, creative approaches in solving, and adapts to rapidly shifting priorities and within a fast-paced environment. The Senior Principal Manufacturing technician sets up and maintains the equipment up to standards. Makes recommendations for continuous improvement of both production work methods in addition to product test methods (TM). Will work directly with other technicians and engineers to complete duties as described below.

• Independently works on multiple project tasks simultaneously for accurate completion, applying time management skills and techniques.
• Ability to take the initiative and work with minimal direction while using good judgement and previous experience for a wide range of activities; including repair and maintenance of production equipment.
• Proactively recommends new ideas and/or improvements pertaining to equipment, fixtures, jigs and process improvements both within the production environment as well as supporting product development activities.
• Lead and mentor other technicians to achieve department and company goals and objectives, which have been assigned.
• Partner with engineers (including Manufacturing and Research & Development) to design and assemble functional prototypes and provide feedback on assembly process, equipment, and fixtures.
• Aid engineers with both product and process development in addition to optimization in support of.
• Initiates root cause investigation and data analysis, applying advanced problem-solving tools and techniques, with the ability to present findings across a wide audience range.
• Perform equipment installation and qualification.
• Lead product and process validation testing requirements, and assist with overall equipment scheduling and utilization in support of
• Prepare test samples (products/materials/solutions) for routine and qualification testing.
• Assist in the transfer of product from R&D into sustained Manufacturing in support of the New Product Introduction efforts, or as part of site transfer and Process Validation requirements for legacy products.
• Develop, update and validate test methods (TM's) used for both product and process development and validate activities.
• Design and fabrication of fixtures and tooling for product builds and testing (i.e. pneumatic, electrical, hydraulic, etc.)
• Responsible for the maintenance and solving of all manufacturing instruments/equipment, along with requirements in support of test method (TM) utilization.
• Create and maintain accurate documentation of preventive and corrective maintenance activities.
• Train other technicians, assemblers and engineers on manufacturing procedures related to product assembly, preventive maintenance, and operator certification/qualification requirements.
• Audit existing and development Manufacturing Process Instructions (MPI's), Work Instructions (WI), etc. and provide recommendations for opportunities in support of continuous improvement initiatives.
• Conduct manufacturing time studies and resulting data analysis in support of line layout and capacity models as required.
• Identify, order, and maintain a safety stock of spare part for all production and product testing equipment, tooling and fixturing.
• Other duties as assigned in support of the essential job functions.

• High School Diploma required with a proven experience as a manufacturing technician (or relevant experience within an Operations environment) in the medical device industry or an Associate's Degree with 5-7 years' experience in the Medical Device industry.
• Previous experience with balloon catheter, drug coating, valve or other cardiovascular medical device process development activities, along with sustained manufacturing support.
• Experience using sketches, CAD, etc. to support the design and build of fixtures.
• Familiar with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP).
• Proficient with MS Office and a solid understanding of basic statistics (utilizing Mini-Tab or similar software).
• Ability to analyze and solve complex technical problems.
• Comfortable working in a clean room environment (CER).
• Ability to communicate effectively with all cross-functional team members, as well both up and down the chain of command within the organization.
• Ability to work in a fast-paced environment while managing multiple high-priority deliverables.
• Operate as part of a team and/or independently while demonstrating flexibility to changing requirements.
• Employee may be required to lift objects up to 25lbs.

• Machine shop and 3D printing experience is preferred.

• The anticipated base pay for this position is $89,000.00 to $124,426.00
• The anticipated travel for this position is 10%