Quality Engineering Manager - Shockwave Medical

Johnson & Johnson MedTech; Santa Clara (CA); On-site; USD 114,000 - 198,000; Full time

Job summary

A leading company in healthcare innovation is seeking a Quality Engineering Manager for Shockwave Medical in Santa Clara, CA. This role involves overseeing quality assurance for innovative medical devices, managing teams, and ensuring compliance with regulatory standards. Ideal candidates will have extensive experience in medical device quality and a strong leadership background. Join a team dedicated to improving health outcomes through cutting-edge technology.

Benefits

Performance bonuses

Health benefits

Retirement plans

Paid time off

Qualifications

• 10+ years in Medical Device Quality, Manufacturing, or Engineering.
• 3+ years supervisory experience.

Responsibilities

• Oversee Catheter Design Quality Assurance Engineering activities.
• Manage and mentor Quality Engineers and Technicians.
• Participate in audits and regulatory submissions.

Skills

Leadership

Communication

Education

Bachelor’s Degree in Engineering

Job description

Quality Engineering Manager - Shockwave Medical

Join to apply for the Quality Engineering Manager - Shockwave Medical role at Johnson & Johnson MedTech.

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

Supply Chain Engineering

Job Sub Function

Quality Engineering

Job Category

Scientific/Technology

Location

Santa Clara, California, United States of America

Job Description

Johnson & Johnson is hiring for a Quality Engineer Manager – Shockwave Medical to join our team located in Santa Clara, CA. We are developing innovative treatments for complex calcified cardiovascular disease, aiming to establish a new standard of care with our proprietary sonic pressure wave technology.

Position Overview

The Quality Engineering Manager provides leadership for Design Quality Engineering programs at Shockwave Medical, supporting the development and compliance of products with regulatory and customer requirements. The role involves managing teams, participating in product design, overseeing validation activities, and ensuring a culture of quality.

Essential Job Functions

• Oversee Catheter Design Quality Assurance Engineering activities.
• Manage and mentor Quality Engineers and Technicians supporting product design and development.
• Participate in new product design and provide quality engineering input.
• Review and approve design verification and validation protocols and reports.
• Support risk management activities and root cause analysis.
• Assist manufacturing with process validation and non-conformance investigations.
• Participate in audits and regulatory submissions.
• Drive continuous improvement projects.

Requirements

• Bachelor’s Degree in Engineering with 10+ years in Medical Device Quality, Manufacturing, or Engineering, including 3+ years supervisory experience.
• Strong knowledge of medical device regulations and quality standards.
• Experience with audits, statistical analysis, and investigation of complaints.
• Excellent communication and leadership skills.
• Ability to work in a fast-paced environment and manage multiple priorities.
• Willingness to work in a Class 100,000 (ISO Class 8) Cleanroom as needed.

Pay Range

Estimated salary range: $114,000 - $197,800. Additional benefits include performance bonuses, health benefits, retirement plans, and paid time off.

Additional Information

Johnson & Johnson is an Equal Opportunity Employer. For accommodations during the interview process, contact [e-mail].