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

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Johnson & Johnson is hiring for a Quality Engineer Manager – Shockwave Medical to join our team located in Santa Clara, CA.

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/.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio 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 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 a 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
Directly responsible for ongoing management, execution and improvements to the following Design Quality Engineering activities:

• Responsible for overseeing all aspects of Catheter Design Quality Assurance Engineering

• Responsible for oversight and management of Quality Engineers and Technicians supporting product design and development activities

  • Leads, supports, and mentors direct reports to develop a highly effective team

  • Sets goals for Design Quality personnel based on Corporate objectives

  • Provides guidance and ensures Quality personnel follow regulations and industry standards

• Participates in New Product Design and Development activities and provides Quality Engineering input, management, and guidance

  • Ensures new Design projects and Design Change activities are performed in compliance with Design Control procedure and relevant regulatory/user requirements

  • Attends design reviews to ensure that the design meets the intended regulatory, internal, and external customer requirements

  • Reviews/ Approves Design Verification and Validation (DV& V) Test Protocols, Methods and Reports

  • Subject Matter Expert on application of relevant standards, test sample sizes and usage of statistical techniques for new Design and Development Projects

  • Oversees verification/ validation activities for Biocompatibility Testing, Packaging Validation, Accelerated and Real Time Shelf-Life/Aging Studies, Sterilization Validation, Test Method Validation, Other DV& V tests

  • Provides technical assistance/guidance and training to the QC function related to inspection methodologies, techniques, processes, and requirements for new products/parts/components

  • Oversees testing and analysis required for the finished device to ensure conformance to product and user specifications

  • Audits DHFs to ensure compliance with Design Control procedure

• Provides guidance in conducting risk management activities including hazard identification, hazard analysis, failure mode effects and analysis, risk mitigation, risk management plans and reports

• Provides support to Manufacturing and Operations:

  • Performs or assists in root cause analysis of product non-conformances found in manufacturing

  • Assists in qualifying molds, fixtures, tooling, and equipment

  • Provides guidance/ approval of process validations

• Reviews, supports investigation, and drive to completion any assigned Complaints, Non-conforming Reports (NCR), Audit Findings and Corrective and Preventive Actions (CAPA)

• Analyzes and reviews data for key Quality metrics to identify any significant trends

• Initiates, reviews, and approves Design Changes and Document Change Orders

• Participates in internal, supplier and third-party audits (FDA, FDB, Notified Body, etc.)

• Supports ongoing Regulatory submission activities and product approval processes

• Assists in planning and executing department growth in line 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 experience. Desire and ability to teach and convey standards and regulations to the organization

• Strong front room audit experience with an ability to effectively 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 up complaint investigations

• Strong background in statistics and statistical analysis

• 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

• Identifies and manages continuous improvement projects with the objective of achieving quality

• Responsible for coaching, training and development of subordinates

• Experience with software validation is preferred

• Must be willing work in a Class 100, 000 (ISO Class 8) Cleanroom as necessary

• May be required to lift objects up to 25lbs

• May be required to travel 10% of the time (domestic and international)

Pay Transparency:

• The anticipated salary range for this position is $114, 000 - $197, 800

• 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. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• 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)).

• This position is eligible to participate in the Company’s long-term incentive program.

• 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

• Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits

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 federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:

Additional Description for Pay Transparency: