Manager, Sustaining Quality Engineering (Hardware/Software)

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.

• Oversee all aspects of sustaining quality activities as it relates to Hardware, Software and Systems engineering.
• Oversee and manage Quality Engineers and Technicians supporting sustaining quality engineering activities:
• Hire, support, and mentor direct reports to develop a highly effective team.
• Set goals for Quality personnel based on corporate objectives.
• Ensure Quality Personnel follow regulations and industry standards.
• Provide visible leadership and oversees daily activities.
• Develop and maintain budget.
• Provide support to Manufacturing and Operations (either at internal site or at external vendor site):
• Establish and maintain validated processes.
• Identify, drive, and implement process improvements.
• Participate in Supplier Quality activities including supplier selection and audits.
• Work with contract manufacturers to maintain product quality and resolve any non-conformances that arise.
• Support business scalability and continuous improvement projects.
• Actively participate in Design Control/Design Change/Supplier Change activities such as:
• Ensure design transfers to manufacturing are completed successfully and in a compliant manner.
• Maintain Risk Management File documents such as Risk Management Plan, ongoing Risk Analysis, Failure Mode and Effects Analysis (FMEA), Risk Management Reports etc.
• Ensure Sustaining projects and Design/Supplier Change activities are performed in compliance to regulations, standards, and internal procedures.
• Draft/Review/Perform Hardware and Software Verification and Validation Test Plan, Test Protocols, Methods, and Reports.
• Audit DHFs to ensure compliance to relevant procedures.
• Subject matter expert on application of relevant standards, test sample sizes and usage of statistical techniques for sustaining and design/supplier/process change projects.
• Drive Standard Gap Assessment activities.
• Ensure compliance to new country requirements prior to product release.
• Investigate and document results for returned devices from clinical studies and commercial complaints.
• Maintain and manage the Servicing Program and coordinate servicing activities with internal and external parties.
• Support Finished Goods distribution and commercial operations Quality activities.
• Support and assist in maintaining compliance with other areas of the QMS as needed (Non-Conformance, Complaints, CAPAs, Post Market Surveillance, Management Responsibility, Supplier Controls, Audit Support, etc.)
• Analyze, review and present data for key Quality metrics to identify any significant trends.
• Initiate, review, and approve Document Change Orders (DCO.)
• 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.

• Bachelor of Science degree in Electrical/Software Engineering. Master's Degree preferred.
• 10+ years of hands-on experience with Hardware and Embedded Software Design, with a minimum of 8 years in the Medical Device industry.
• Experience with Analog and Digital Circuit Design, schematic layouts, PCB Layout/ design and prototype development.
• Experience with embedded systems, source version control, Issue Tracking, and control electronics for use in medical devices and programming.
• 2+ years of experience managing others, or other equivalent experience.
• Working knowledge of applicable medical device regulations and standard such as ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP required.
• Experience with statistical software such as Minitab and the application of valid statistical techniques for data analysis.
• Experience with Class III medical device experience and electromechanical device product is highly desired.
• Experience and involvement with complaint investigations is preferred.
• Ability to understand regulatory implications of Design/Process/Supplier Changes.
• Ability to lead cross-functional teams in problem solving and risk analysis activities.
• Must be able to communicate effectively with all levels of the organization in both verbal and written formats.
• Highly proficient in MS Word, Excel and Power Point.
• High attention to detail and accuracy is required.
• 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.
• Employee must be able to travel 25% of the time.

Market Range:

$144,000 - $180,000

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: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer