Senior Technician, Laboratory

Edwards Lifesciences; Irvine (CA); On-site; USD 52,000 - 73,000; Full time

Job summary

A leading company in structural heart innovation is seeking a Senior Technician, Laboratory to join the THV Quality Engineering team on-site in Irvine, CA. The role involves critical inspections and testing related to product quality, requiring strong communication and problem-solving skills. Ideal candidates will have experience in a lab environment and an educational background in Engineering or a Scientific field.

Qualifications

• 3 years of lab experience with an Associate’s degree or 1 year with a Bachelor’s.
• Knowledge of Good Documentation Practices (GDP).
• Experience in a medical device or healthcare environment preferred.

Responsibilities

• Perform routine inspections and testing for device investigations.
• Support clinical case evaluations and risk assessments.
• Manage complaint device workflow and laboratory equipment maintenance.

Skills

Attention to detail

Problem-solving

Critical thinking

Communication skills

Education

Associate’s degree in Engineering or Scientific field

Bachelor’s degree in Engineering or Scientific field

Tools

Leankit

Power BI

Job description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Technician, Laboratory position is a unique career opportunity that could be your next step towards an exciting future.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. 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.

This position will be in THV Quality Engineering, Global Product Surveillance (GPS). The GPS team is responsible for leading and performing critical engineering investigations on globally reported complaints for returned/non-returned devices. The role is not remote and will require presence on campus.

Please note this is an "onsite" role, and the successful candidate will be expected to work from our corporate Irvine, CA campus.

How you will make an impact:

• Responsibilities mainly include, but not limited to, performing routine and non-routine inspection and testing as needed for device investigations and supporting engineering evaluations for product failure analysis (root cause analysis). This includes collecting and processing data for the engineering team for assessment and complaint evaluations.
• Supporting evaluations that consist of clinical case evaluations, manufacturing record reviews, IFU/Training reviews, and risk assessments to determine if escalations are required for further action.
• Helping to manage the complaint device workflow from receipt, through laboratory investigation, archive, and disposal. Enforcing 6S approach to laboratory maintenance (i.e. equipment, inventory, processes).
• Providing support and management of laboratory equipment ensuring proper PM (preventative maintenance) or calibration per established schedule.
• Utilizing data management tools (i.e. Leankit, PowerBI dashboards) for inventory management and investigation prioritization.

What you’ll need (Required):.

• An Associate’s degree in Engineering or Scientific field with 3 years of previously related experience in a lab environment OR a Bachelor’s degree in Engineering or Scientific field with 1 year of previously related experience in a lab environment Required.

What else we look for (Preferred):

• Knowledge and experience working in a laboratory environment
• Experience working in a medical device, healthcare, or a related environment preferred
• Exposure to data management tools (i.e. Leankit and Power BI) and Quality Management systems
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills
• Full knowledge of Good Documentation Practices (GDP)
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
• Ability to build stable working relationships internally.

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, the base pay range for this position is $52,000 to $73,000 (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 Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

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.

For US Applicants Only

Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, the California Fair Chance Act, and any other applicable regulation.