About the position
Johnson & Johnson is hiring for a Sr. Principal Manufacturing Technician - Shockwave Medical to join our team located in Santa Clara, CA. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Responsibilities
- 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.
Requirements
- 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.
Benefits
- Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Consolidated retirement plan (pension) and savings plan (401(k)).
- Vacation - up to 120 hours per calendar year.
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year.
- Holiday pay, including Floating Holidays - up to 13 days per calendar year.
- Work, Personal and Family Time - up to 40 hours per calendar year.
