R&D Assembler II - Shockwave Medical

Johnson & Johnson Innovative Medicine•Santa Clara, CA

1d•Onsite

About The Position

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 https://www.jnj.com/. 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. 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 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.

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

Administrative Support
Agile Manufacturing
Assembly Operations
Detail-Oriented
Execution Focus
Factory Acceptance Test (FAT)
Good Manufacturing Practices (GMP)
Innovation
Learning Agility
Manufacturing Processes
Manufacturing Science and Technology (MSAT)
Mechanical Equipments
Plant Operations
Process Oriented
Prototyping
Repair Management
Structural Fabrication
Technologically Savvy

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.
Other duties as assigned.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits