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

All Job Posting Locations:

US360 MN New Brighton - 600 County Road D W

Job Description:

Johnson & Johnson is hiring for a Senior Quality Engineer, Shockwave Medical to join our Design and Manufacturing Team located in New Brighton, MN.

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/.

Shockwave Medical, Inc., recently acquired by Johnson & Johnson, is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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 Senior Quality Engineer will serve as a key contributor to both the design and manufacturing teams, actively engaging cross-functionally to solve complex technical challenges. This position plays a critical role in making strategic decisions regarding project scope, risk management, design updates, process optimization, and material disposition. The Senior Quality Engineer will oversee the implementation of updated specifications to ensure full compliance with quality and regulatory standards. This role includes the development and execution of verification and validation protocols, defining clear acceptance criteria, and producing detailed reports that drive continuous improvement in product and process performance. The ideal candidate will offer innovative solutions and support the successful execution of quality engineering activities across the product lifecycle.

Essential Job Functions

• Develop, apply, and maintain robust quality standards for materials, components, and products, ensuring full alignment with regulatory and company requirements.
• Design and implement advanced methods and procedures for inspection, testing, and evaluation to assess the precision and accuracy of products, sub-assemblies, and production equipment.
• Prepare comprehensive documentation, including inspection/testing procedures, validation protocols, quality plans, and product defect investigations. Ensure technical documents are clear, accurate, and meet regulatory requirements. Review and provide feedback on technical documents from peers.
• Independently evaluate whether products meet specifications and initiate corrective actions for non-conformances in collaboration with cross-functional teams.
• Serve as a subject matter expert in quality engineering, providing technical leadership in quality standards, process control, and compliance.
• Collaborate with manufacturing and development engineers to establish and enhance process controls, optimize documentation, and drive continuous improvement through data-driven insights.
• Drive continuous improvement initiatives using tools such as Lean, Six Sigma, or similar methodologies to optimize processes, reduce defects, and improve overall product quality.
• Take ownership of complex tasks, performing them independently while managing technical complexity and making key decisions, seeking guidance only for non-routine challenges.
• Lead detailed phases of engineering work within major projects, ensuring timelines and goals are met.
• Supervise, coordinate, and mentor engineers, technicians, and cross-functional team members on project-specific assignments, fostering a collaborative environment that promotes continuous improvement and the development of junior engineers in quality engineering practices
• Participate in design reviews and pre-validation assessments to ensure proper process controls are in place. Provide leadership in risk management efforts in product development, including conducting FMEA, risk assessments, and failure mode evaluations to ensure device safety and compliance.
• Collaborate closely with regulatory affairs and compliance teams to ensure the timely preparation and submission of regulatory filings, as well as compliance with global regulations.
• Address complex challenges such as conflicting design requirements or material incompatibility, leveraging broad engineering knowledge and precedent.
• Apply knowledge of FDA guidance, ISO, and ASTM standards to ensure compliance with relevant regulations.
• Ensure adherence to Health, Safety, and Environmental compliance standards, following Federal, State, and local regulations.
• Conduct internal and supplier audits to ensure compliance with ISO13485:2016 and other relevant standards. Lead Auditor certification is a plus.
• Investigate customer complaints and provide comprehensive technical reports based on device performance and investigation data. Communicate findings with customers when necessary.
• Maintain calibration standards for tools and equipment used across R&D, Manufacturing, and Quality areas.
• Utilize statistical tools such as Minitab for process capability assessments, data analysis (normality, variance), hypothesis testing, sample size determination, design of experiments (DOE), and application of sampling plans.
• Perform additional duties as assigned, contributing to team success.

Qualifications - External

• Education/Certifications: * Bachelor’s degree in a related engineering discipline with 5+ years of medical device industry experience; OR * Master’s degree in a related engineering discipline with 3+ years of medical device industry experience. * Quality Engineer (CQE), Six Sigma, and Lead Auditor Certification is a plus.
• Regulatory/Compliance Knowledge: * In-depth understanding of medical device regulations (e.g., ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP).
• Technical Skills * Strong technical writing skills, with the ability to create clear, accurate, and regulatory-compliant documents. * Experience in customer complaint investigations, failure analysis, and complaint report writing. * Proven ability to provide manufacturing support in a Quality Engineering capacity. * Familiarity with balloon catheter technology is a strong plus.
• Experience: * Design Verification and Validation (DV&V) protocol writing and review experience. * Experience generating documentation for manufacturing line transfers and site validations is highly preferred. * Experience in leading or participating in continuous improvement initiatives using methodologies such as Lean, Six Sigma, or similar, to optimize processes and reduce defects. * Experience using Product Lifecycle Management (PLM) and Manufacturing Execution Systems (MES) to oversee the full development lifecycle and manufacturing processes of medical devices, ensuring traceability, compliance, and efficient workflows.
• Work Style: * Proactive and self-motivated, with the ability to work independently and manage complex tasks with minimal supervision.
• Able to manage multiple priorities in a fast-paced, dynamic environment and adjust to evolving requirements.
• Strong communication skills with the ability to effectively collaborate with all levels of management and teams.
• Other Requirements: * Willingness to travel up to 10% of the time. * Ability to lift objects up to 25lbs.

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 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)).
• 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 of 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

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

The anticipated base pay range for this position is :

$77,000 to $124,200

Additional Description for Pay Transparency:

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.