Quality Engineer II (Shift B)
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
The Quality Engineer II 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. Supports or provides solutions to broad problems, accomplishes assignments of various complexity, develops protocols for design, and/or process activities (including those related to verifications or validations), 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.
• With minimal support, 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.
• Plans and conducts work requiring judgment in the evaluation, selection, adaptation and modification of standard techniques, procedures, and criteria. Provides support to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices.
• Performs most assignments with some guidance and with an understanding of the overall expectations. Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
• May be required to plan, schedule, conduct, and coordinate detailed phases of engineering work as part of new or on-going projects.
• Familiarity with FDA guidance documents and ISO and ASTM standards related to quality and medical device industry is an asset.
• With minimal guidance, assesses if components, sub-assemblies, and 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 pre-validation assessments to support 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 others who assist in specific assignments.
• Practices company safety, quality policies and procedures.
• 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.
• 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 2+ years of related experience; or MS in a related engineering discipline
• Experience in the medical device industry is required
• 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
• Certified as a lead auditor in ISO13485:2016 would be an asset. Familiarity with IEC 60601 and IEC 62304 is an asset. 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
• Ability to operate with minimal guidance and adaptability to changing requirements
• Ability to work in a fast-paced environment, managing multiple priorities
Benefits
Shockwave Medical offers competitive total compensation packages in line with market requirements.