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.



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, designchanges, process improvements, material disposition, and implementation of revised specifications.Provides and develops solutions to broad problems, accomplishes complex assignments, developsprotocols for design, and/or process activities, (including those related to verification or validationactivities), determines criteria and subsequently generates summary (or final) reports.

Essential Job Functions:

• Responsible for developing, applying, revising and maintaining quality standards for processingmaterials/products into partially or finished products.
• Designs and implements methods and/or procedures for inspecting, testing and evaluating theprecision and accuracy of products, components, sub-assemblies and/or production equipment.
• Prepares documentation for inspection/testing procedures, development studies, validationprotocols and reports, quality plans, and product defect investigations. Must be able to write atechnical document with sufficient clarity, detail and correctness to be submitted for regulatoryreview with confidence. Must be able to review and provide value-added feedback to otherswriting such documents.
• Fully competent engineer in all conventional aspects of the subject matter, functional area, andassignments.
• 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 onproposed plans for projects.
• Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a majorproject.
• Performs work which involves conventional engineering practice but may include a variety ofcomplex 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 ofprinciples and practices of related specialties. Familiarity with FDA guidance documents and ISOand ASTM standards related to quality and medical device industry is an asset.
• Independently assesses if components, sub-assemblies, products meet specification and caninitiate, investigate and resolve non-conformances by working in conjunction with a multidisciplinaryteam.
• Responsible for ensuring personal and company compliance with all Federal, State, local andcompany regulations, policies and procedures for Health, Safety and Environmental compliance.
• May participate in design reviews and pre-validation assessments to ensure the safe andenvironmentally sound start-up of new processes, and ensure the process has adequate andappropriate process controls. May be responsible for participating and/or taking lead role indeveloping the risk management plan for new projects transitioning into manufacturing. (Hazardassessment, design trace matrix development, DV&V testing, and FMEA).
• May technically supervise or coordinate the work of engineers, technicians, and others who assistin specific assignments.
• May conduct internal and supplier audits. Certified as a lead auditor in ISO13485:2016 would bean asset. Familiarity with IEC 60601 and IEC 62304 is an asset.
• Processing, investigating, and completing customer complaints, which could require direct emailresponses to customers.
• Composes technical complaint reports timely and accurately based on reported information anddevice investigation data.
• Responsible for developing and maintaining calibration requirements for tools and equipment inthe R&D, Manufacturing, and Quality areas.
• Knowledge of statistics and Minitab, including process capability and data normality assessments,analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance intervalassessments for variable and attribute data, design of experiment (DOE), and variable and attributesampling plan applications would be a great asset.
• Other duties as assigned.

Requirements:

• BS in a related engineering discipline and 5+ years of related experience; or MS in a relatedengineering 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
• Experience with balloon catheters and electrical systems is strongly preferred
• 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 linetransfer to alternative sites
• Certified Quality Engineer would be an asset
• 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

Market Range: $102,489 - $124,501
Exact compensation may vary based on skills, experience, and location.