Job Function: R&D Product Development
Job Sub Function: Biomedical Engineering
Job Category:Scientific/Technology
All Job Posting Locations:Santa Clara, California, United States of America
Job Description:Johnson & Johnson is hiring for a Principal R&D Engineer - Shockwave Medical to join our team located in Santa Clara, CA.
Position OverviewThe Principal R&D Engineer will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Principal R&D Engineer will participate on multiple cross-functional development teams that manage projects from concept through commercialization.
Essential Job Functions- Provide technical leadership for projects including managing technology development teams
- Responsible for managing technology and other relevant resources.
- Design and develop product(s) in compliance with the company's Design Control requirements and consistent with applicable regulatory requirements.
- Prototype and develop proof of concept designs, disease models and test methods of testing these concepts in a simulated environment and develop new product designs based on the defined user needs.
- Work with clinical and scientific advisors as well as Key Opinion Leaders in translating clinical needs into design solutions while utilizing these resources to develop and optimize product design.
- Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping and pilot operation.
- Participate as SME or core team member on product development team(s) that manage projects from concept through commercialization.
- Responsible for ensuring proper documentation consistent with company's quality system.
- Responsible for knowing and planning activities consistent the company's quality policy and quality objectives.
- Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing.
- Perform process-related design tasks to support pilot manufacturing as necessary.
- Identify suppliers and maintain relationships to ensure the delivery of superior components and services.
- Enhance the intellectual property position of the company via invention disclosures and patent applications.
- 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 for new products being developed.
- Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations.
- Other duties as assigned.
Requirements- Bachelor's Degree in Mechanical or Biomedical Engineering and 10 years' experience in engineering OR a Master's Degree and 8 years' experience in engineering.
- Engineering experience in the medical device industry.
- Experience developing disposable medical devices.
- Knowledge of disposable peripheral and coronary device design, material selection, and testing.
- Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
- Experience in early-stage catheter based cardiovascular devices development is a strong plus.
- Strong hands-on experience with CAD software like Solidworks.
- Effective communication skills with all levels of management and organizations.
- Operate independently and adaptability to changing requirements.
- Ability to work in a fast-paced environment, managing multiple priorities.
- Previous experience managing cross functional teams is preferred.
- Employee may be required to lift objects up to 25lbs.
Required Skills:Preferred Skills:Bioinformatics, Biological Engineering, Biostatistics, Clinical Trials Operations, Coaching, Communication, Critical Thinking, Global Market, Healthcare Trends, Medical Affairs, Organizing, Product Development, Project Reporting, Research and Development, Researching, Resource Planning, SAP Product Lifecycle Management
The anticipated base pay range for this position is :$134,000.00 - $231,150.00
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)).
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
