Quality Engineer I
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 I 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:
- Provide support to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices.
- With guidance, 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 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 accuracy to be submitted for regulatory review with confidence. Must be able to review and provide value-added feedback to others writing such documents.
- With 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. Participate in developing the risk management plan for new projects transitioning into manufacturing. (Hazard assessment, design trace matrix development, DV&V testing, and FMEA).
- Process, investigate, and complete customer complaints.
- Compose technical complaint reports timely and accurately based on reported information and device investigation data.
- May be required to plan, schedule, conduct, and coordinate detailed phases of engineering work as part of new or on-going projects.
- Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
- Practices company safety, quality policies and procedures.
- May assist in conducting internal and supplier audits.
- Other duties as assigned.
Requirements:
- BS or MS in a related engineering discipline
- At least 1 year of experience in the medical device industry is preferred.
- Familiarity with customer complaint investigations, complaint report writing, and providing manufacturing support as a Quality Engineer is preferred
- An understanding of balloon catheters and electrical systems is strongly preferred
- Basic understanding with FDA, ISO 13485 and other applicable regulations related to quality and medical device industry
- 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 is preferred
- Must be proactive and self-motivated
- Strong technical writing skills are required
- Effective communication skills
- Ability to operate with some guidance and adaptability to changing requirements
- Ability to work in a fast-paced environment, managing multiple priorities
- Must be willing to travel up to 10% of the time
Benefits
Shockwave Medical offers competitive total compensation packages in line with market requirements.