R&D Engineer II (Process Development) – Shockwave Medical

Johnson & Johnson; Santa Clara (CA); On-site; USD 86,000 - 138,000; Full time

Job summary

Join a pioneering firm in the medical device industry as an R&D Engineer II, where you'll leverage your engineering skills to develop innovative products aimed at treating complex cardiovascular diseases. This role is integral in overseeing process development and ensuring compliance with quality standards. Collaborate with cross-functional teams to transition products from development to full production, while optimizing processes and validating designs. If you are passionate about engineering and eager to make a difference in healthcare, this opportunity offers a dynamic work environment with significant impact on patient care.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Performance Bonus

Vacation Time

Sick Leave

Holiday Pay

Qualifications

• 2+ years experience in engineering or 1 year with a Master's degree.
• Engineering experience in the medical device industry is highly preferred.

Responsibilities

• Support product development for manufacturing in compliance with FDA and ISO.
• Participate in cross-functional teams from concept through commercialization.

Skills

Mechanical Engineering

Biomedical Engineering

Communication Skills

Project Management

Material Selection

Design for Reliability

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Master’s degree in Mechanical or Biomedical Engineering

Tools

Lab Notebooks

SOP Documentation

Job description

Job Description - R&D Engineer II (Process Development) – Shockwave Medical (2506235937W)

R&D Engineer II (Process Development) – Shockwave Medical to join our R&D team located in Santa Clara, CA.

Shockwave Medical, Inc., recently acquired by Johnson & Johnson, is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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 Engineer II will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The R&D Engineer II will focus on process development for the engineering team, providing 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 R&D Engineer II will develop, validate, and implement various processes by working closely with research/development, operations, regulatory, and quality teams.

Essential Job Functions

• Support the development of product(s) for manufacturing in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDR requirements.
• Work on prototype and develop designs, processes, and test methods in support of new product designs scaling for commercialization.
• Represent R&D on manufacturing-related project activities, including internal and external requests.
• Analyze, evaluate, source, and coordinate 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 with 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.
• Write 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.
• 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.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering with 2+ years’ experience in engineering or a master’s degree in Mechanical or Biomedical Engineering with 1 year of engineering experience preferred.
• Engineering experience in the medical device industry is highly preferred.
• Knowledge of disposable peripheral and coronary device design, material selection, and testing preferred.
• 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 base pay range for this position is $86,000 to $138,000 annually.
• 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.
• 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)).
• 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.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.