Edwards Lifesciences · 14 hours ago
Engineer II, Post Market Surveillance
Irvine, CA
Full-time
Hybrid
Entry, Mid Level
$85K/yr - $120K/yr
2+ years expEdwards Lifesciences is focused on delivering innovative solutions in the medical device industry, particularly for patients with cardiovascular disease. The Engineer II, Post Market Surveillance role is crucial for monitoring device performance post-commercialization, ensuring safety and effectiveness through data analysis and process improvements.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Participate in, and own escalation tasks and activities including Product Risk Assessment (PRAs) and Corrective/Preventive action(s) (CAPAs) as appropriate based on issue investigation
Identify and own improvement projects associated with the optimization of internal processes through the utilization of engineering methods (e.g. Six Sigma and LEAN)
Identify and report key complaint metrics per device category and collaborate with applicable manufacturing/R&D teams to investigate and resolve device related issues. Update and maintain technical content of risk management files
Train, coach, and guide lower-level employees on routine procedures
Perform other duties and responsibilities as assigned
Qualification
Required
Bachelor's degree in Engineering or a Scientific field
Minimum of 2 years of experience in engineering and/or compliance within the medical device or pharmaceutical industry
Proven hands-on experience managing processes and workflows in highly regulated environments, ensuring adherence to strict compliance and quality standards
Preferred
Advanced degree in a relevant field
Experience within the medical device industry, with a strong understanding of industry standards and practices
Knowledge of applicable MDR and FDA regulations governing the medical device industry
Knowledge of risk management principles and practices
Proficiency in MS Office Suite and other relevant software tools
Exceptional documentation and communication skills (written and verbal), with strong interpersonal and consultative abilities
Strong problem-solving, organizational, analytical, and critical thinking skills
Ability to interact professionally and effectively across all organizational levels
Proven ability to manage competing priorities in a fast-paced environment
Collaborative team player with experience managing project stakeholders and driving results
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Andrew Greene
Vice President, Strategy
Recent News
bloomberglaw.com
2026-01-20
BioWorld Financial Watch
2026-01-15
Orange County Business Journal
2026-01-14
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