Sr RD Engineer Process Development Shockwave

Johnson & Johnson; Santa Clara (CA); On-site; USD 121,000 - 195,000; Full time

Job summary

A leading healthcare company seeks a Sr. R&D Engineer (Process Development) in Santa Clara, CA, to pioneer the development of innovative products for treating cardiovascular conditions. Candidates should have a degree in Mechanical or Biomedical Engineering and relevant experience in medical device engineering. This role offers competitive compensation and comprehensive employee benefits.

Benefits

Medical, dental, and vision insurance

401(k) savings plan

Vacation and sick time

Annual performance bonus

Long-term incentive program

Qualifications

• 5 years’ experience in engineering or 3 years with a master's degree in engineering.
• Strong understanding of engineering materials and component selection.
• Experience in early-stage catheter-based cardiovascular devices.

Responsibilities

• Develop product(s) for manufacturing in compliance with design control and regulatory requirements.
• Participate in cross-functional development teams managing projects from concept to commercialization.
• Support pilot manufacturing and product verification and validation testing.

Skills

Engineering experience

Communication skills

Flexibility

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Master’s degree in Engineering

Tools

Design Control

FDA regulations

ISO standards

MDR requirements

Job description

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

Job Function:

R&D Product Development

Job Sub Function:

R&D Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a **Sr R &D Engineer (Process Development) – Shockwave **to join our team located in Santa Clara, CA.

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 Sr. R&D Engineer will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Sr. R&D Engineer will act as the subject matter expert for the engineering team, provide oversight to pilot manufacturing/testing, and see products transition from development into full production. This position will participate on multiple cross-functional development teams that focus on process optimization, sustaining, and design support. The Sr. R&D Engineer will develop, validate, and implement various processes by working closely with research/development, operations, regulatory, and quality teams.

Essential Job Functions

• Develop product(s) for manufacturing in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDR requirements
• Prototype and develop designs, processes, and test methods in support of new product designs scaling for commercialization
• Represents R&D as a primary point of contact on manufacturing-related project activities, including internal and external requests.
• Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping and pilot operation
• Participate on 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 the company’s quality policy and quality 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 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

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 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 while 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

Additional Information:

The anticipated salary range for this position is $121,000-$194,350

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be 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.
• Employees are eligible for the following time off benefits:
  • Vacation – up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays – up to 13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States.

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 and 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 email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$121,000-$194,350

Additional Description for Pay Transparency: