Sr. Quality Engineer- Shockwave Medical

Johnson & Johnson-posted 3 days ago

$91,000 - $147,200/Yr

Full-time • Mid Level

Santa Clara, CA

5,001-10,000 employees

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Johnson & Johnson is hiring for a Sr Quality Engineer for Shockwave Medical Inc. 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 Sr. Quality Engineer will support manufacturing and work cross-functionally to resolve technical problems. Participates in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications. Provides and develops solutions to broad problems, accomplishes complex assignments, develops protocols for design, and/or process activities, (including those related to verification or validation activities), determines criteria and subsequently generates summary (or final) reports.

Responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products.
Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment.
Analyzes nonconformance reports and returned products and recommends corrective action.
Prepares documentation for inspection/testing procedures, development studies, 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.
Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
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 major 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 is an asset.
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 ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
Responsible for participating in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes, and ensure the process has adequate and appropriate process controls.
Responsible for participating and/or taking lead role in developing the risk management plan for new projects transitioning into manufacturing. (Hazard assessment, design trace matrix development, DV&V testing, and FMEA).
May technically supervise or coordinate the work of engineers, technicians, and others who assist in specific assignments.
Practices company safety, quality policies and procedures, and actively requires conformance.
May conduct internal and supplier audits.
Processing, investigating, and completing customer complaints, which could require direct email responses to customers.
Composes technical complaint reports timely and accurately based on reported information and device investigation data.
Responsible for developing and maintaining calibration requirements for tools and equipment in the R&D, Manufacturing, and Quality areas.
Other duties as assigned.

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 skills are required
Experience in customer complaint investigations and complaint report writing
Experience in manufacturing support as a Quality Engineer
Must be proactive, self-motivated, and work independently with minimal supervision
Must be willing to travel up to 10% of the time
Effective communication skills with all levels of management and organizations
Operate independently and adaptability to changing requirements
Ability to work in a fast-paced environment, managing multiple priorities

Experience with balloon catheters, automated machines and electrical systems with software validation is strongly preferred
Experience with Extrusion and Braiding is a plus
Experience in completing Medical Device Reports (MDR) and Vigilance (MDV) submissions is an asset
Experience in writing and reviewing design verification and validation protocols
Preferred experience in generating documentation and criteria for validation of manufacturing line transfer to alternative sites
Certification and/or license in a specific discipline would be an asset
Certified Quality Engineer would be an asset
Certified as a lead auditor in ISO13485:2016 would be an asset.
Familiarity with IEC 60601 and IEC 62304 is an asset.
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.

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 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
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

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