R&D Assembler II - Shockwave Medical

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. 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 an 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 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. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. 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. 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 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. 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. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: 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 The anticipated base pay range for this position is : $40,250.00 - $64,802.50 Additional Description for Pay Transparency: 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)). For additional general information on Company benefits, please go to: - 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 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 Do Not Sell or Share My Personal Information Limit the Use of My Personal Information