Logo of Huzzle

Home

Matches

Explore

Manage

Sr. R&D Engineer (Clinical Engineering) - Shockwave

image

Johnson & Johnson

2mo ago

  • Job
    Full-time
    Mid & Senior Level
  • Research & Development
    Engineering
  • Santa Clara

AI generated summary

  • You need a bachelor’s in Mechanical/Biomedical Engineering (5 years' experience) or a master’s (3 years). Preferably, you have medical device experience, especially with catheter-based cardiovascular devices.
  • You will design, prototype, test, and document medical products, ensuring compliance with quality standards while managing materials and supplier relationships in cross-functional teams.

Requirements

  • Bachelor’s degree in Mechanical or Biomedical Engineering with 5 years’ experience in engineering or a master’s degree with 3 years’ experience in engineering
  • Engineering experience in the medical device industry is highly preferred
  • Knowledge of disposable peripheral and coronary device design, material selection, and testing
  • Strong foundation in basic science including engineering principles, anatomy, and physiology
  • 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
  • Effective communication skills with all levels of management and organizations
  • 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

Responsibilities

  • Design and develop product(s) in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDD 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
  • Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation
  • Participate in cross-functional development team 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 with the company’s quality policy and quality objectives
  • Responsible for ensuring that 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 pilot manufacturing
  • 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 for new products being developed
  • Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations
  • Other duties as assigned

FAQs

What is the location for the Sr. R&D Engineer position?

The position is located in Santa Clara, CA.

What are the main responsibilities of the Sr. R&D Engineer?

The main responsibilities include designing and developing products in compliance with regulatory requirements, prototyping, analyzing materials, participating in cross-functional teams, ensuring documentation quality, developing testing protocols, and maintaining supplier relationships.

What qualifications are required for this position?

The position requires a Bachelor’s degree in Mechanical or Biomedical Engineering with 5 years of experience, or a Master’s degree with 3 years of experience in engineering, preferably within the medical device industry.

Is experience in the medical device industry necessary?

Yes, engineering experience in the medical device industry is highly preferred.

What type of products will the Sr. R&D Engineer focus on?

The engineer will focus on innovative products to treat peripheral, coronary, and heart valve diseases, particularly in the development of Intravascular Lithotripsy (IVL).

What is the anticipated salary range for this position?

The anticipated salary range is $103,000 - $165,600.

Are there performance bonuses associated with this position?

Yes, this position is eligible for an annual performance bonus based on individual and company performance.

What employee benefits are offered?

Employees may be eligible for medical, dental, vision, life insurance, 401(k), vacation, sick time, and a long-term incentive program, among others.

How many vacation hours are employees entitled to per year?

Employees can earn up to 120 hours of vacation per calendar year.

Is experience with catheter-based cardiovascular devices a plus for this role?

Yes, experience in early-stage catheter-based cardiovascular device development is considered a strong plus.

What level of communication skills is required for this position?

Effective communication skills with all levels of management and organizations are required.

Are there physical requirements for the position?

Yes, employees may be required to lift objects up to 25 lbs.

Does Johnson & Johnson have a commitment to equal opportunity employment?

Yes, Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer and ensures all qualified applicants receive consideration for employment without discrimination.

Where can more information about benefits be found?

Additional information about employee benefits can be found at the Johnson & Johnson careers website: https://www.careers.jnj.com/employee-benefits.

image

Johnson & Johnson

Hospitals and Health Care

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Profound Change Requires Boldness. Johnson & Johnson is the largest and most diversified healthcare products company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world.