Senior R&D Engineer – Cardio MedTech Leadership

Johnson & Johnson Innovative Medicine; Santa Clara (CA); On-site; USD 134,000 - 231,000; Full time

Benefits offered by this job

Vacation 120 hours/year

Sick time 40 hours/year (Colorado/Wash

Floating Holidays 13 days

Job summary

Johnson & Johnson is hiring a Principal R&D Engineer – Shockwave Medical to join our team in Santa Clara, CA. You will lead multi-disciplinary teams to develop and bring to market next-gen intravascular lithotripsy devices, translating clinical needs into innovative design solutions and ensuring compliance with Design Control and regulatory requirements.

The role involves prototyping, testing (in-vitro/in-vivo), supplier management, documentation, and collaboration with clinicians and KOLs to

Qualifications

• Bachelor’s Degree in Mechanical or Biomedical Engineering and 10 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.

Responsibilities

• 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.

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

Education

Bachelor’s Degree in Mechanical or Biomedical Engineering

Master’s Degree in Engineering

Tools

Solidworks

Job description

Johnson & Johnson is hiring a Principal R&D Engineer – Shockwave Medical to join our team in Santa Clara, CA. You will lead multi-disciplinary teams to develop and bring to market next-gen intravascular lithotripsy devices, translating clinical needs into innovative design solutions and ensuring compliance with Design Control and regulatory requirements.

The role involves prototyping, testing (in-vitro/in-vivo), supplier management, documentation, and collaboration with clinicians and KOLs to