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
Position Overview
The Quality Engineer I (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 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.
Essential Job Functions
- Support to R&D (Design Control):
- Ensure new Design projects and Design Change activities (including design reviews) are performed in compliance to Design Control procedure.
- Draft Design Verification and Validation Test Protocols, Methods and Reports.
- With guidance, can communicate 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), Risk Management Plans and Reports.
- Provide support for verification/ validation activities for: Biocompatibility Testing, Packaging Validation, Accelerated and Real Time Shelf-Life/Aging Studies, Sterilization Validation, Test Method Validation.
- With guidance, identify testing and analysis required for the finished device to ensure conformance to product specifications.
- Assist with developing device Quality Plans to ensure that the elements of the Quality Management System are appropriately described and managed.
- Assist with auditing DHFs to ensure compliance to Design Control procedure.
- Support to Manufacturing and Operations:
- Assist in root cause analysis of product non-conformances found in manufacturing.
- Assist in qualifying molds, fixtures, tooling, and equipment.
- Support process validations.
- Identify and support process improvements.
- Participate in Supplier Quality activities including material non-conformances and Supplier audits.
- Assist contract manufacturers to maintain product quality and resolve any non-conformances that arise.
- Assist in recommending 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)
- Initiate, review, and approve Document Change Orders (DCO)
- Assist with 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.
Requirements
- Bachelor of Science degree in a related engineering discipline
- At least 1 year of medical device industry experience is preferred
- Basic Understanding of FDA, ISO 13485, and other applicable regulations related to quality and the 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
Market Range: $75,000 - $94,000
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