Quality Engineering Manager – Shockwave Medical

Johnson & Johnson – Quality Engineer Manager – Shockwave Medical

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

Job Posting Location:

• Santa Clara, California, United States of America

Position Overview

The Quality Engineering Manager provides leadership for Design Quality Engineering programs at Shockwave Medical. Works on problems and projects of moderate to complex scope where analysis of situation or data requires review of identifiable factors. Participates in decisions on scope of work, risk management, length of tasks and compliance pathways. Supports project teams to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines. This manager will play a key role in building and sustaining a culture of Quality throughout the organization.

Essential Job Functions

• Oversee all aspects of Catheter Design Quality Assurance Engineering
• Manage Quality Engineers and Technicians supporting product design and development activities
• Lead, support, and mentor direct reports to develop a highly effective team
• Set goals for Design Quality personnel based on Corporate objectives
• Provide guidance and ensure Quality personnel follow regulations and industry standards
• Participate in New Product Design and Development activities, providing Quality Engineering input, management, and guidance
• Ensure new Design projects and Design Change activities comply with Design Control procedures and regulatory/user requirements
• Attend design reviews to ensure design meets regulatory, internal, and customer requirements
• Review and approve Design Verification and Validation (DV&V) Test Protocols, Methods, and Reports
• Serve as Subject Matter Expert on relevant standards, test sample sizes, and statistical techniques for new Design and Development Projects
• Oversee verification/validation activities such as Biocompatibility Testing, Packaging Validation, Shelf-Life Studies, Sterilization Validation, Test Method Validation, and other DV&V tests
• Provide technical assistance and training to QC function regarding inspection methodologies and requirements for new products
• Oversee testing and analysis to ensure finished devices conform to specifications
• Audit Device History Files (DHFs) to ensure compliance with Design Control procedure
• Provide guidance on risk management activities including hazard identification, failure mode effects and analysis, risk mitigation, and management plans
• Support Manufacturing and Operations through root cause analysis of product non-conformances
• Assist in qualifying molds, fixtures, tooling, and equipment
• Provide guidance and approval of process validations
• Review and drive resolution of Complaints, Non-conforming Reports (NCR), Audit Findings, and CAPA
• Analyze data for key Quality metrics to identify trends
• Initiate, review, and approve Design Changes and Document Change Orders
• Participate in internal, supplier, and third-party audits (FDA, FDB, Notified Body, etc.)
• Support ongoing Regulatory submission activities and product approvals
• Assist in planning and executing department growth aligned with Company goals and budget
• Other duties as assigned

Requirements

• Bachelor’s Degree in an engineering discipline with 10 years’ experience in Medical Device Quality, Manufacturing, or Engineering including 3+ years of supervisory experience
• Excellent understanding of medical device regulations with strong quality knowledge and teaching ability
• Strong audit experience with ability to present and defend quality systems
• Strong analytical and problem-solving skills
• Excellent written and verbal communication and leadership skills
• Experience investigating customer complaints and writing investigations
• Strong background in statistics and statistical analysis
• Ability to manage multiple priorities in a fast-paced environment
• Ability to work independently and as part of a team with flexibility
• Experience leading continuous improvement projects
• Responsible for coaching, training and development of subordinates
• Experience with software validation preferred
• Must be willing to work in a Class 100,000 (ISO Class 8) Cleanroom as necessary
• May be required to lift up to 25 lbs
• May be required to travel up to 10% (domestic and international)

Pay Transparency

• The anticipated salary range for this position is $114,000 – $197,800
• Eligible for annual performance bonus based on individual and company performance
• Employee benefits include medical, dental, vision, life insurance, disability, accident insurance, and group legal insurance
• Eligibility for retirement plans (pension, 401(k)) and long-term incentive program
• Time off benefits include vacation (up to 120 hours/year), sick time, holidays, and personal/family time
• Additional benefit information: https://www.careers.jnj.com/employee-benefits

Equal Opportunity Employer Statement

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 law. We actively seek qualified protected veterans and individuals with disabilities.

We are committed to providing an inclusive interview process. If you require accommodation, please contact the Employee Health Support Center at [email protected] or AskGS.