Shockwave Medical, Inc. 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.
Shockwave Medical Inc. is looking for an enthusiastic, motivated candidate to be a Senior Quality Engineer working on 2nd shift (typical shift start is at 2:00pm) in our dynamic environment. The Senior Quality Engineer will work on projects and problems of moderate complexity in scope where analysis of the situation or the data requires a review of recognizable and distinguishable factors. Participates in decisions on scope of work, risk management, design changes, 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. May provide technical guidance to lower level personnel.
Essential Job Functions
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 non-conformance 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 relates 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, actively requires conformance.
May conduct internal and supplier audits. Certified as a lead auditor in ISO13485:2016 would be an asset. Familiarity with IEC 60601 and IEC 62304 is an asset.
Responding to complaints from customers and investigating the root cause. Completing Medical Device Report (MDR) and Vigilance (MDV) submissions.
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.
Experience in writing and review design verification and validation protocols would be an asset.
Experience in generating documentation and criteria for validation of manufacturing line transfer to alternative sites would be an asset.
Must be able to work 2nd shift (typical shift is from 2pm-11pm)
BS in a related engineering discipline; and 58 years of related experience; or MS in a related engineering discipline and 46 years of related experience.
Experience in the medical device industry is strongly preferred.
Certification and/or license in specific discipline would be an asset.
Certified Quality Engineer would be an asset.
Shockwave Medical offers a competitive total compensation package including comprehensive benefits (medical, dental, vision) as well as pet insurance and student loan refinancing support.
Shockwave Medical, Inc.