Overview
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
Job Information
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
Position
Johnson & Johnson is hiring for a Sr. Quality Engineer – Shockwave Medical 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.
Responsibilities
- 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
- Write technical documents with sufficient clarity for regulatory submission and provide feedback to others writing such documents
- Plan and conduct work requiring judgment in the independent evaluation and modification of standard techniques, procedures, and criteria
- Provide guidance to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices
- Independently perform most assignments with an understanding of overall expectations
- Receive technical guidance on unusual problems and obtain supervisory approval on proposed project plans
- Plan, schedule, conduct, and coordinate detailed phases of engineering work within a project
- Perform work involving conventional engineering with potential for complex features and coordination requirements
- Apply broad knowledge of precedents in the specialty area and familiarity with FDA guidance documents and ISO standards related to quality and medical devices
- Independently assess if components, sub-assemblies, products meet specification and resolve non-conformances with a multi-disciplinary team
- Participate in design reviews and product transition to contract manufacturers/suppliers ensuring compliance with external regulations and internal procedures
- Participate in or lead updating risk management plans for manufacturing projects/products (hazard assessment, design trace matrix, DV/V testing, FMEA)
- Audit DHFs to ensure compliance with the Design Control procedure
- Review, investigate, disposition, and drive to completion Non-conforming Reports (NCR) and CAPAs
- Initiate, review, and approve Document Change Orders (DCO)
- Support internal and supplier audits; familiarity with ISO13485 lead auditing is an asset; familiarity with ISO 14971, IEC 60601 and IEC 62304 is an asset
- Process, investigate, and complete customer complaints, including direct email responses
- Support Servicing Program and coordinate servicing activities
- Support regulatory submission activities and product approval processes
- Knowledge of statistics and Minitab used for process capability and data analysis tasks
- Understand and apply Johnson & Johnson’s Credo and Leadership Imperatives
- 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
- 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
- Must be proactive, self-motivated, and work independently with minimal supervision
- Experience in writing and reviewing design verification and validation protocols is a plus
- Certification and/or license in a specific discipline is a plus; Certified Quality Engineer is a plus
- Willingness to travel
- Effective communication skills with all levels of management
- High attention to detail and accuracy
- Proficiency in MS Word, Excel and PowerPoint
- Operate independently with minimal support and adapt to changing requirements
- Ability to work in a fast-paced environment with 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 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 in 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 birth/adoption/foster care; Condolence Leave – 30 days for an immediate family member; Caregiver Leave – 10 days; Volunteer Leave – 4 days; Military Spouse Time-Off – 80 hours. Additional information can be found at
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