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R&D Assembler II - Shockwave
R&D Assembler II - ShockwaveJohnson & Johnson MedTech • Santa Clara, CA, US
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R&D Assembler II - Shockwave

R&D Assembler II - Shockwave

Johnson & Johnson MedTech • Santa Clara, CA, US
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Join to apply for the R&D Assembler II - Shockwave role at Johnson & Johnson MedTech.

Job Overview

Johnson & Johnson MedTech is hiring a R&D Assembler II located in Santa Clara, CA to support the development and commercialization of Intravascular Lithotripsy (IVL) and Shockwave Medical portfolio.

Position 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 role records Lot History Records (LHRs) and other Quality Records, complies 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, creates effective interpersonal relationships, and displays 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 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 MPI, SOP, 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.
  • May be required to lift objects up to 15 pounds and sit for prolonged periods.
  • Compensation and Benefits

  • Anticipated hourly range : $18.79–$29.88.
  • Eligible for an annual performance bonus per company plan.
  • Eligible for long-term incentive program and consolidated retirement plan (401(k)).
  • Eligible for medical, dental, vision, life insurance, short- and long-term disability, and group legal insurance.
  • Time-off benefits : up to 120 vacation hours per calendar year, up to 40 sick hours per calendar year (56 hours for Washington residents), up to 13 holiday days per calendar year, and up to 40 hours per calendar year for work, personal, and family time.
  • Work is full-time.
  • Equal Opportunity Employer

    Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by federal, state, or local law.

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