R&D Assembler II - Shockwave

Johnson & Johnson • Santa Clara, CA

69d • $18 - $29

About The Position

Johnson & Johnson is hiring for a R&D Assembler II to join our team located in Santa Clara, CA. 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.

Requirements

• High school diploma or equivalent experience.
• Must be able to read and communicate in English.
• Must be able to use various hand tools to assemble small parts.
• 1-3 years of experience in a manufacturing environment with small parts.
• Medical device manufacturing experience is preferred.
• Must be able to work in and abide by Controlled Environment Room (CER) procedures.
• Ability to assemble, and test medical devices, including soldering, gluing, and assembly under the microscope while following Manufacturing Process Instructions (MPI), Standard Operating Procedures (SOP), Work Instructions (WI), etc.
• Requires moderate supervision for routine work and close supervision for special assignments.
• Capable of filling out detailed LHRs while following Good Documentation Practices (GDP).
• Ability to work in a fast-paced environment while adhering to SWMI safety standards.
• Ability to work overtime to accommodate business needs.
• Reliable attendance.
• There may be continuous sitting for prolonged periods and may be required to lift objects up to 15 pounds.

Nice To Haves

• Experience in medical device manufacturing.

Responsibilities

• Cleans workstations/equipment and performs line clearance per documented procedures.
• Builds prototypes, subassemblies, and/or final assemblies per MPIs or engineering documentation.
• Performs in‑process inspections of components/materials, subassemblies, and final assemblies to ensure that specifications are met for data collection and analysis.
• Uses documented guidelines provided by engineers and provides feedback for improved manufacturing methods to assist in the product development process.
• Monitors equipment parameters and results of in‑process inspection(s); as necessary, adjusts according to documented procedures to ensure product meets appropriate quality specifications.
• Prepares labels, audits labeled product for product information per LHRs and assembles final product packaging.
• Records and dispositions labeling materials used, destroyed, and leftover from packaging operations, as required.
• Ensures that only products labeled correctly are released to finished goods (if applicable) according to documentation.
• Prepares packaging for shipment, adheres to inventory control labeling, and verifies that quantity of boxed product matches quantity recorded on LHR, as required.
• Records details of work and completes required portions of LHR to ensure traceability of each finished product lot.
• Assists R&D team with inventory control issues (e.g., qualified equipment, commercial materials, etc.).
• Documents scrap resulting from out-of-specification equipment, materials, processes (i.e., non-conforming materials) according to documented procedures and notifies R&D Engineering/Supervisor that disposition and/or corrective action may be required.
• Adheres to SWMI safety standards.
• Trained and certified to multiple processes utilized across product development.
• Implements 5S practices and Lean Manufacturing principles.
• Promotes a positive teamwork environment, create effective interpersonal relationships, and display good communication skills.
• Communicates clearly with co-workers and peers.

Benefits

• Medical, dental, vision, life insurance.
• Short- and long-term disability.
• Business accident insurance.
• Group legal insurance.
• Consolidated retirement plan (pension).
• Savings plan (401(k)).
• Long-term incentive program.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees