Principal R&D Engineer – IVL Medical Devices

Biopharma Careers; Santa Clara (CA); On-site; USD 180,000 - 250,000; Full time

Job summary

Johnson & Johnson is seeking a Principal R&D Engineer – Shockwave Medical for its Santa Clara, CA location. Lead cross-functional teams to develop intravascular lithotripsy solutions, overseeing design controls, prototyping, and validation activities to advance cardiovascular interventions.

You will collaborate with clinical advisors and KOLs to translate clinical needs into robust product designs, manage material procurement, ensure quality documentation, and drive projects from concept to

Qualifications

• Experience leading multi-disciplinary product development teams.
• Experience with designing and developing medical devices under Design Control.
• Ability to translate clinical needs into design solutions with advisors and KOLs.
• Experience with prototype, concept testing, and validation testing.

Responsibilities

• Provide technical leadership for cross-functional development teams.
• Design and develop products in line with Design Control and regulatory requirements.
• Prototype proof-of-concept designs and conduct testing in simulated environments.
• Collaborate with clinical advisors and KOLs to translate needs into designs.
• Manage procurement and evaluation of materials for prototyping.
• Prepare documentation per the quality system.
• Plan activities aligned with the company's quality policy and objectives.
• Perform in-vitro and in-vivo validation testing and pilot process tasks.
• Identify suppliers and maintain relationships for components and services.

Skills

Technical leadership

Cross-functional collaboration

Design controls

Prototype and testing

Regulatory compliance

Project management

Job description

Johnson & Johnson is seeking a Principal R&D Engineer – Shockwave Medical for its Santa Clara, CA location. Lead cross-functional teams to develop intravascular lithotripsy solutions, overseeing design controls, prototyping, and validation activities to advance cardiovascular interventions.

You will collaborate with clinical advisors and KOLs to translate clinical needs into robust product designs, manage material procurement, ensure quality documentation, and drive projects from concept to