Safety Engineer Jobs in Irvine, CA

INTRODUCTION

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

ROLE AND RESPONSIBILITIES

The Senior Director, Global Clinical Safety - THV will lead global clinical safety strategy and a team of subject matter experts to ensure patient safety, regulatory compliance, and successful clinical program execution. Partner cross-functionally to identify and mitigate risks, guide decision-making at the executive level, and drive high-impact safety initiatives across the business.

This role requires onsite presence at our corporate headquarters in Irvine, CA.

You will make an impact by:

• Managing a team of clinical and medical safety SMEs and related activities within an assigned business unit
• Directing clinical and medical safety activities with overall responsibility of developing systems, planning, staffing, budgeting, managing expense priorities, recommending and implementing changes to methods through several managers. Developing a robust talent development and succession planning in alignment with functional growth strategies across the global clinical safety organization
• Mitigating/eliminating risk, directing and communicating highly complex clinical safety strategies which includes negotiations with internal and external parties
• Planning and directing strategic activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives. Leading in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams
• Analyzing, formulating and presenting recommendations to advise and guide executive level leadership; developing and delivering executive level communication

BASIC QUALIFICATIONS

What you'll need (Required):

• Bachelor's Degree in related field experience in clinical trial safety required or equivalent work experience based on Edwards criteria
• 10-15 years of related experience in clinical research or industry

PREFERRED QUALIFICATIONS

What else we look for (Preferred):

• Advanced degree required (MD, PharmD, PhD, MS) or equivalent scientific discipline
• Experience working in a regulated industry or clinical trial safety
• Demonstrated track record in people management
• Certification in related field or equivalent work experience based on Edwards criteria
• Proven successful project management leadership skills
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

COMPENSATION

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $191,000 to $271,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.