Shockwave Medical Careers

Description

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.

Description

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.

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.
• Prepares documentation for inspection/testing procedures, development studies, validation protocols and reports, quality plans, and product defect investigations. 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.
• 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 multidisciplinary 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.
• May participate 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. May be 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.
• 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.
• 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.
• 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.
• 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 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 line transfer 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.