Manager, Sustaining Quality Engineering (Hardware/Software)

$144,000 - $180,000/Yr

Shockwave Medical - Santa Clara, CA

Full-time - Manager

Santa Clara, CA

Merchant Wholesalers, Durable Goods

About the position

The Manager, Sustaining Quality Engineering (HW/SW) at Shockwave Medical, Inc. leads the Sustaining Quality Engineering group, ensuring the delivery of safe and effective medical devices in compliance with company policies and regulatory standards. This role involves overseeing hardware and software product life cycle management, supporting project teams, and executing initiatives for quality improvement and product safety.

Responsibilities

• Oversee all aspects of sustaining quality activities related to Hardware, Software, and Systems engineering.
• Manage Quality Engineers and Technicians, including hiring, mentoring, and setting goals based on corporate objectives.
• Ensure compliance with regulations and industry standards by Quality personnel.
• Develop and maintain budget for the Sustaining Quality Engineering group.
• Support Manufacturing and Operations by establishing and maintaining validated processes.
• Identify and implement process improvements in collaboration with contract manufacturers.
• Participate in Supplier Quality activities, including supplier selection and audits.
• Ensure successful and compliant design transfers to manufacturing.
• Maintain Risk Management File documents and ensure compliance with regulations and standards.
• Draft, review, and perform Hardware and Software Verification and Validation Test Plans and Reports.
• Conduct audits of Design History Files (DHFs) for compliance.
• Drive Standard Gap Assessment activities and ensure compliance with new country requirements prior to product release.
• Investigate and document results for returned devices from clinical studies and commercial complaints.
• Manage the Servicing Program and coordinate servicing activities with internal and external parties.
• Support Finished Goods distribution and commercial operations Quality activities.
• Analyze and present data for key Quality metrics to identify trends.
• Initiate, review, and approve Document Change Orders (DCO).
• Participate in internal, supplier, and third-party audits.
• Support ongoing Regulatory submission activities and product approval processes.
• Participate in the implementation and continuous improvement of the Quality Management System.

Requirements

• 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 medical devices.
• 2+ years of experience managing others or equivalent experience.
• Working knowledge of medical device regulations and standards such as ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP.
• Experience with statistical software such as Minitab and valid statistical techniques for data analysis.
• Experience with Class III medical devices and electromechanical products is highly desired.
• Experience 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.
• Effective communication skills with all levels of the organization in both verbal and written formats.
• Highly proficient in MS Word, Excel, and PowerPoint.
• High attention to detail and accuracy is required.
• Ability to work in a fast-paced environment while managing multiple priorities.

Nice-to-haves

• Experience and involvement with complaint investigations is preferred.

Benefits

• Medical, Dental, Vision insurance
• Pre-tax and Roth 401k options with a fully vested match
• Short-Term and Long-Term Disability
• Life Insurance
• Employer contribution toward Health Savings Account (HSA)
• Competitive PTO balance
• Calm App
• Pet Insurance
• Student Loan Refinancing
• Spot Bonus awards