R&D Assembler II Shockwave Medical

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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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 by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats 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.

Essential Job Functions

• Cleans workstations/equipment and performs line clearanceper documented procedures.

• Builds prototypes subassemblies and/or final assemblies per MPIs or engineering documentation.

• Performs inprocess 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 inprocess 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 ( equipment commercial materials etc.).

• Documents scrap resulting from out-of-specification equipment materials processes (-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.

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