Staff R&D Electrical Engineer, Systems - Shockwave Medical

Johnson & Johnson Innovative Medicine•Santa Clara, CA

20h

About The Position

Johnson & Johnson is hiring for a Staff R&D Electrical Engineer, Systems – 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 Staff R&D Electrical Engineer, Systems will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Staff R&D Electrical Engineer, Systems will support product testing, sub-system/component qualification and design, and serve on multiple cross-functional initiatives for projects ranging from concept through commercialization.

Requirements

Bachelor’s degree in Electrical or Biomedical Engineering with 8+ years’ experience, or a master’s degree with 6+ years’ experience Engineering experience in the medical device industry
Experience with Altium circuit design CAD suite preferred
Experience in analysis and testing of electronic circuits at the component level
Strong understanding of engineering materials, component selection, and design for reliability and manufacturability
Working knowledge of IEC 60601-1, IEC 60601-1-2, and other collateral standards
Experience designing, assembling, and qualifying fixtures used for design verification, bench testing, and manufacturing needs
Experience with JAMA requirements management system preferred
Experience with JIRA preferred
Effective communication skills with all levels of management (internal and external)
Ability to work in a fast-paced environment, managing multiple priorities
Operate as a team and/or independently while demonstrating flexibility to changing requirements
Employee may be required to lift objects up to 25lbs

Nice To Haves

Accelerating
Coaching
Critical Thinking
Design Mindset
Feasibility Studies
Process Improvements
Product Design
Product Knowledge
Program Management
Prototyping
Research and Development
Robotic Automation
SAP Product Lifecycle Management
Smart Systems
Technical Research
Technical Writing
Technologically Savvy

Responsibilities

Design, develop, and root cause product(s) in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDD/MDR requirements
Prototype and develop proof of concept designs and test methods in a simulated environment, and develop new designs based on the defined user and project needs
Analyze, evaluate, source, and coordinate the procurement of new materials to support product development and operational initiatives
Participate on cross-functional teams that manage projects in various stages, from concept through commercialization and sustaining.
Responsible for ensuring proper documentation consistent with company’s quality system
Responsible for designing fixtures and sub-systems, aligned with project goals
Responsible for execution of design verification testing, including those against recognized standards such as 60601-1, 60601-1-2, and others associated with the electro-mechanical equipment in the medical device industry.
Responsible for executing projects consistent with the company’s priorities and strategic objectives
Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP
Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing
Perform process-related design tasks to support transitioning designs into a manufacturing environment
Identify suppliers and maintain relationships to ensure the delivery of superior components and services
Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products
Responsible for component and assembly documentation
Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations
Other duties as assigned

Benefits

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.
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