Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the recent acquisition of Neovasc and their innovative Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina - long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide. Together, we are working to bring these patients relief from their symptoms and hopefully improve their quality of life. Position Overview The Sr. Quality Engineer (Design Assurance) 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. Provides 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, MDSAP and other applicable regulations. 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. This candidate must be able to work onsite in the New Brighton, MN office a minimum of 3 days a week. 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. 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 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. Provide support to Manufacturing and Operations: 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. 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 Qual ty Management System. Provide technical support to the Quality inspection group. Other duties as assigned. Requirements Bachelor of Science degree in a related engineering discipline and 5+ years of medical device industry experience; or Master of Science in a related engineering discipline and 3+ years of medical device industry experience Working knowledge of applicable medical device regulations such as ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP required. Ability to perform multiple tasks concurrently with accuracy. Ability to understand regulatory implications of Design Changes. Experience and involvement with complaint investigations, is preferred. Participate in cross-functional team efforts in problem solving and risk analysis activities Must have demonstrated hands-on experience in: Design Verification and Validation Hazard/Risk Analysis Design/Usability/Process FMEA Reliability and Stability Testing Biocompatibility/Sterilization FDA Good Manufacturing Practices (GMP) Must be able to communicate effectively with all levels of the organization in both verbal and written formats Proficiency in MS Word, Excel and Power Point required High attention to detail and accuracy is required Experience with statistical software such as Minitab and/or Statgraphics and the application of valid statistical techniques for data analysis. Ability to work in a fast-paced environment while managing multiple priorities. Operate as a team and/or independently while demonstrating flexibility to changing requirements. Employee may be required to lift objects up to 25lbs. Market Range: $96,000 - $120,000 Exact compensation may vary based on skills, experience, and location. Benefits Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks: Core Benefits:Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards EEO Employer Shockwave Medical Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.