Hardware and Software Product Lifecycle Manager
6 days ago
We are seeking an experienced Hardware and Software Product Lifecycle Manager to join our team at Shockwave Medical. This role will involve providing leadership and technical expertise to our Sustaining Quality Engineering group, ensuring that our medical devices meet the highest standards of quality and safety.
Key Responsibilities:- Lead cross-functional teams in problem-solving and risk analysis activities.
- Develop and implement process improvements to enhance quality and efficiency.
- Maintain and manage the servicing program and coordinate servicing activities with internal and external parties.
- Analyze and review data for key quality metrics to identify trends and areas for improvement.
- 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.
- Working knowledge of applicable 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 required.
We offer a highly competitive salary range of $144,000 - $180,000 per year, based on skills, experience, and location, along with 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.
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