R&D Assembler II - Shockwave Medical

Johnson Johnson; Santa Clara (CA); On-site; USD 52,000 - 72,000; Full time

Job summary

Johnson & Johnson is hiring for an R&D Assembler II- Shockwave Medical to join our team in Santa Clara, CA. This role focuses on assembling, testing, and inspecting in-development devices under guidance from R&D Engineers and Supervisors.

Responsibilities include line clearance, batch traceability, and maintaining quality records while adhering to safety policies and Lean principles. Requires a high school diploma and ability to read/communicate in English.

Qualifications

• Must read and communicate in English.
• High school diploma or equivalent required.
• Experience in a manufacturing/assembly environment preferred.

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 to ensure specifications are met for data collection and analysis.
• Monitors equipment parameters and adjusts as necessary to ensure quality.

Skills

English communication

Education

High school diploma or equivalent

Job description

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Assembly

Job Category:

Business Enablement/Support

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a R&D Assembler II- 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. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 plaquPosition Overview

The R&D Assembler II is responsible for assembly, testing, and inspection of in-development, non-commercial product according to direction and documentation provided by R&D Engineers and/or Supervisor. The R&D Assembler II records functions and activities performed on Lot History Records (LHRs) and other Quality Records, as appropriate. The R&D Assembler II will also comply with documented requirements, company policies and procedures, including quality, safety, and environmental policies.

Essential Job Functions

• 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.
• Other duties as assigned.

Requirements

• High school diploma or equivalent experience.
• Must be able to read and communicate in English.
• Must be able to use various ha