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:

Santa Clara, California, United States of America

Job Description:

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

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 Sr. Quality Engineer works closely with internal departments to efficiently support delivering safe and effective medical devices which are in line with Shockwave Medical Inc. (SWMI)/Johnson and Johnson policies and procedures. This position represents Quality Assurance for hardware and software sustaining engineering activities to drive improvements with respect to hardware and equipment. This includes supporting project teams to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines as well as working closely with Design, Manufacturing Engineering and Contract Manufacturers to improve processes where possible. Provides Quality Assurance support to functions with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC 62366 and IEC 60601. Provides leadership to the finance operations team including Forecasting, Reporting, Compliance, Financial Systems and Compliance.

Essential Job Functions:

• Work with contract manufacturers to maintain product quality and resolve any non-conformances

• Prepares documentation for inspection/testing procedures, development studies, verification/validation protocols and reports, quality plans, product defect investigations and inspection plans.

• Must be able to write a technical document with sufficient clarity, detail and correctness to be submitted for regulatory review with confidence. Must be able to review and provide value-added feedback to others writing such documents.

• Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.

• Provides guidance to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices.

• Independently performs most assignments with an understanding of the overall expectations.

• Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.

• Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a project.

• Performs work which involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of conventional materials, and difficult coordination requirements.

• Work requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of related specialties. Familiarity with FDA guidance documents and ISO and

• ASTM standards related to quality and medical device industry.

• Independently assesses if components, sub-assemblies, products meet specification and can initiate, investigate and resolve non-conformances by working in conjunction with a multi-disciplinary team.

• Responsible for participating in design reviews and product transition to contract manufacturers/suppliers, and ensure the activities meet external regulations, industry standards, and internal procedures.

• Responsible for participating and/or taking lead role in updating the risk management plan for projects/products in manufacturing. (Hazard assessment, design trace matrix development, DV&V testing, and FMEA).

• Audit DHFs to ensure compliance with the Design Control procedure.

• Review, investigate, disposition, and drive to completion Non-conforming Reports (NCR) and Corrective and Preventive Actions (CAPA.)

• Initiate, review, and approve Document Change Orders (DCO.)

• Support internal and supplier audits. Certified as a lead auditor in ISO13485 would be an asset. Familiarity with ISO 14971, IEC 60601 and IEC 62304 is an asset.

• Processing, investigating, and completing customer complaints, which could require direct email responses to customers.

• Support Servicing Program and coordinate servicing activities with internal and external parties

• Support ongoing Regulatory submission activities and product approval processes.

• Knowledge of statistics and Minitab, including process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications would be a great asset.

• J&J Credo: Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day to day interactions with team.

• Other duties as assigned

Requirements

• BS in a related engineering discipline and 5+ years of related experience; or MS in a related engineering discipline and 3+ years of related experience

• Experience in the medical device industry is highly preferred

• Strong technical writing and verbal skills are required

• Experience in customer complaint investigations and complaint report writing

• Experience in contract manufacturing support as a Quality Engineer

• Ability to lead cross-functional teams in problem solving and risk analysis activities

• Must be proactive, self-motivated, and work independently with minimal supervision

• Experience in writing and reviewing design verification and validation protocols would be an asset

• Certification and/or license in a specific discipline would be an asset.

• Certified Quality Engineer would be an asset

• Must be willing to do some minimal travel

• Effective communication skills with all levels of management and organizations

• High attention to detail and accuracy is required

• Proficiency in MS Word, Excel and Power Point required

• Operate independently with minimal support and adaptability to changing requirements

• Ability to work in a fast-paced environment, managing multiple priorities

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 & 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 contact us via https://www.jnj.com/contact-us/careers_ or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$89,000 - $142,600

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

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.

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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.