Quality Engineering Manager
6 days ago
**About the Role:**
We are seeking a seasoned Quality Engineering Manager to lead our Sustaining Quality Engineering team at Shockwave Medical, Inc. The successful candidate will provide leadership and oversight to ensure compliance with industry regulations and company standards.
**Key Responsibilities:**
- Oversight of sustaining quality activities for hardware, software, and systems engineering.
- Management of Quality Engineers and Technicians supporting sustaining quality engineering activities.
- Hiring, developing, and mentoring direct reports to build a high-performing team.
- Setting goals for Quality personnel aligned with corporate objectives.
- Ensuring Quality personnel follow applicable medical device regulations and standards.
- Providing visible leadership and overseeing daily activities.
- Developing and maintaining budgets.
- Supporting Manufacturing and Operations teams.
- Establishing and maintaining validated processes.
- Identifying and implementing process improvements.
- Participating in Supplier Quality activities, including supplier selection and audits.
**Requirements:**
- Bachelor of Science degree in Electrical/Software Engineering; Master's Degree preferred.
- 10+ years of hands-on experience in 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 equivalent experience.
- Working knowledge of applicable medical device regulations and standards.
- Experience with statistical software such as Minitab and valid statistical techniques for data analysis.
- Class III medical device experience and electromechanical device product highly desired.
- Ability to understand regulatory implications of Design/Process/Supplier Changes.
- Ability to lead cross-functional teams in problem-solving and risk analysis activities.
- Strong communication skills, both verbal and written.
**What We Offer:**
- A competitive salary range of $144,000 - $180,000 based on skills, experience, and location.
- A comprehensive benefits package, including medical, dental, vision, pre-tax and Roth 401k options, short-term and long-term disability, life insurance, employer contribution toward Health Savings Account (HSA), and competitive PTO balance.
- Calm App, Pet Insurance, Student Loan Refinancing, and Spot Bonus awards.
**About Us:**
Shockwave Medical, Inc. is an Equal Opportunity Employer.
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