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 (Hardware/Software) at Shockwave Medical is responsible for leading the Sustaining Quality Engineering group, ensuring that medical devices are developed and manufactured in compliance with regulatory guidelines. This role involves overseeing quality assurance processes, managing a team of quality engineers, and collaborating with various departments to enhance product safety and quality while supporting continuous improvement initiatives.

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 quality engineering activities.
• Support Manufacturing and Operations by establishing and maintaining validated processes.
• Identify and implement process improvements in collaboration with contract manufacturers.
• Participate in Design Control/Design Change/Supplier Change activities to ensure compliance and successful design transfers.
• Draft, review, and perform Hardware and Software Verification and Validation Test Plans and Reports.
• Audit Design History Files (DHF) for compliance with relevant procedures.
• Investigate and document results for returned devices from clinical studies and commercial complaints.
• Analyze and present data for key Quality metrics to identify trends.

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 and programming 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.

Nice-to-haves

• Experience with Class III medical devices and electromechanical products.
• Involvement with complaint investigations.

Benefits

• 401(k) matching
• Dental insurance
• Disability insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off