Senior Quality Engineering - Shockwave Medical

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 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.

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 produc