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Principal Quality Engineer

Company: Shockwave Medical, Inc.
Location: Morgan Hill
Posted on: February 21, 2021

Job Description:

DescriptionShockwave 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 OverviewThe Principal Quality Engineer works closely and partners with internal departments to efficiently deliver safe and effective medical device designs for manufacturing, which are in line with Shockwave Medical Inc. (SWMI) policies and procedures. Provide Quality Assurance support to functions with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP. This includes supporting project teams to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines as well as working closely with Design and Manufacturing Engineering to improve processes where possible.Essential Job Functions* Actively participate in Design Control activities such as:* Ensure new Design projects and Design Change activities are performed in compliance to Design Control procedure.* Design reviews to document and ensure that the design meets the intended customer requirements.* Draft Design Verification and Validation Test Protocols, Methods and Reports.* Subject Matter Expert on application of relevant standards, test sample sizes and usage of statistical techniques for new Design and Development Projects.* Lead and responsible for ongoing management of Risk Analysis, Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA.), Risk Management Plans and Reports.* Perform Design Verification and Validation Testing.* Lead/Coordinate/perform verification/ validation activities for:* Biocompatibility Testing.* Packaging Validation.* Accelerated and Real Time Shelf-Life/Aging Studies.* Sterilization Validation.* Test Method Validation.* Provide support to Manufacturing and Operations:* Evaluate/investigate and document investigation results for returned devices from clinical studies and commercial complaints.* Review, investigate, disposition, and drive to completion Non-conforming Reports (NCR) and Corrective and Preventive Actions (CAPA.)* Analyze and review data for key Quality metrics to identify any significant trends.* Initiate, review, and approve Document Change Orders (DCO.)* Drive Standard Gap Assessment activities.* Participate in internal, supplier and third-party audits (FDA, FDB, Notified Body, etc.)* Support ongoing Regulatory submission activities and product approval processes.* Participate in the implementation and continuous improvement of the Quality Management System.* Provide technical support to the Quality inspection group.* Other duties as assigned.* Identify testing and analysis required for the finished device to ensure conformance to product specifications.* Develop device Quality Plans to ensure that the elements of the Quality Management System are appropriately described and managed.* Audit DHFs to ensure compliance to Design Control procedure.* Perform or assist in root cause analysis of product non-conformances found in manufacturing.* Assist in qualifying molds, fixtures, tooling, and equipment.* Perform/support process validations.* Identify, drive, and implement process improvements.* Participate in Supplier Quality activities including material non-conformances and Supplier audits.* Work with contract manufacturers to maintain product quality and resolve any non-conformances that arise.* Recommend QC sampling plans based on desired confidence and reliability limits.Requirements* Bachelor's degree or equivalent experience. Bachelor's degree in science, math, engineering, or medical fields is preferred.* Minimum 2 years of experience in a regulatory position in a regulated healthcare industry.* Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations* Experience with pre- and post-market medical device submissions support such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers, and/or international filings (TGA, Health Canada, Shonin, CFDA, etc.).* Exercise good and ethical judgment within policy and regulations* Think analytically with good problem solving skills* Clear and effective verbal and written communication skills with diverse audiences and personnel* Proficiency in MS Word, Excel, Adobe and Power Point* Ability to work collaboratively in a fast-paced environment while managing multiple priorities* Operate as a team and/or independently while demonstrating flexibility to changing requirements.* Some medical device software engineering background or experience is preferredBenefitsShockwave Medical offers a competitive total compensation package including comprehensive benefits (medical, dental, vision) as well as pet insurance and student loan refinancing support.EEO Employer

Keywords: Shockwave Medical, Inc., Mountain View , Principal Quality Engineer, Engineering , Morgan Hill, California

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