R&D Supervisor - Shockwave Medical

Johnson & Johnson•Santa Clara, CA

35d•Onsite

About The Position

Johnson & Johnson is hiring for an R&D Supervisor- 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 Supervisor is responsible for directing the activities of R&D Assemblers and R&D Technicians engaged in manufacturing pre-commercial medical devices in a clean room environment. The R&D Supervisor is also responsible for training and supervising employees, ensuring compliance with the safety and quality standards established by the company, and other supervisory activities such as time and attendance management. The R&D Supervisor is required to supervise all assembly activities performed by employees, maintaining a high degree of visibility and access to employees throughout the shift.

Requirements

Bachelor's degree or equivalent experience.
Minimum 3 years of experience as a Lead and a minimum of 2 years of experience as a supervisor.
Medical device experience, preferably with catheter products.
Experience with Microsoft Office or similar computer software.
Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations, and good manufacturing practices (GMP).
Ability to work in a clean room environment.
Excellent written and oral communication skills.
Strong interpersonal and communication skills with the ability to clearly provide work direction, communicate with support staff and present recommendations and ideas and to build consensus.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.

Responsibilities

Establishes and maintains department standards for safety, productivity, reliability, and accuracy.
Works closely with R&D engineers to support experimental builds across multiple projects using provided documentation. Retains responsibility for various pre-commercial products ranging from initial prototype assembly through design verification.
Establishes and maintains department standards for safety, productivity, reliability, and accuracy.
Communicates regularly with R&D project teams and other functions, as needed, in support of planning, managing, and executing operational objectives.
Establishes and maintains department standards for safety, productivity, reliability, and accuracy.
Assists in failure analysis, troubleshooting, rework/repair of non-conforming manufactured product to determine root cause.
Estimates materials, tools and supply requirements and provides coordination of fulfillment.
Troubleshoots work problems with employees; conveys a sense of urgency and drives issues to closure.
Participates in developing new procedures and processes to improve manufacturing of products during development phase.
Manages staffing through coaching and development, employment decisions and resolving employee issues through problem resolution.
Develops direct reports by securing appropriate training, assigning progressively challenging tasks, rewarding positive behavior, and applying disciplinary action as appropriate.
Monitors daily work metrics and provides direction and guidance to skilled non-exempt staff to achieve unit or project goals.
Maintains a constant line presence and a working knowledge of all operating systems pertaining to the work area.
Manages staffing through coaching and development, employment decisions and resolving employee issues through problem resolution.
Assists in time studies to quantify processing times and identifies areas for process improvements.
Adapts to frequent changes in the work environment; manages multiple tasks and competing demands.
Work with buyers to order supplies for CERs and R&D projects.
Maintain inventory count of materials for all R&D projects and replenish as needed.
Order and pick up materials from warehouse for R&D projects.
Escort contractor for drop-off and pick-up of clean room garments weekly

Benefits

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
long-term incentive program
Vacation -120 hours per calendar year
Sick time - 40 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
Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave - 10 days
Volunteer Leave - 4 days
Military Spouse Time-Off - 80 hours