Senior Technician, Quality & R&D Engineering Laboratory Testing

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.
The Senior Technician will provide operational support for product testing and technology transfer activities and independently run and manage lab operations.
How you will make an impact:

• Lead and execute maintenance of testing equipment, equipment calibrations, and inspection tooling, fixtures/models, or gauges, including TFIQ and functional verification.
• Asset management in MAXIMO. Perform process & equipment start up.
• Lead and execute equipment's routine re-validation for business continuity.
• Writes and leads TFIQ and IQ validation activities: prepare protocols and reports to validate new or existing equipment. Support engineers in validation or re-validation execution on new or existing equipment.
• Investigate, troubleshoot (failure mode analysis), execute and recommend resolution (cause and effect analysis) of any deviations or non-conformances relative to process and equipment. Provide proper documentation as required.
• Work with Original Equipment Manufacturers (OEMs) to implement equipment changes and technical troubleshooting.
• Establish equipment operating procedures/work instructions and maintenance checklists.
• Ensure timely procurement and maintenance of equipment spares and consumables.
• Provide coaching and guidance to technicians or team members.
• Supports and manages lab scheduling with other project teams.
• Adheres to all applicable GMP and GDP requirements when performing work.
• On occasion, execute Test Method Validation (TMV), MSA/ GR&R.
• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer (when necessary) work period.
• Other incidental duties as assigned by Management.

What you'll need: (Required Qualifications):

• Associate degree or technical degree/certificate with (2) years of experience in an R&D Lab and/or medical device industry; OR (4) years of overall lab experience within a GLP and/or GMP environment providing engineering support with design, quality, manufacturing, or new product development activities.
• Experience testing lab related equipment and/or with equipment maintenance and proper documentation of asset management.
• Experience working within a highly regulated environment.

What else we look for: (Preferred Qualifications):

• Experience within medical device, pharma, biotech, food, automotive, or aerospace industries.
• Experience developing and executing validations protocols, including writing installation qualifications (IQs & TFIQs).
• Demonstrated experience preparing protocols and reports to validate new or existing equipment.
• Familiar with software validation requirements and testing protocols.
• Performing studies and executing protocols associated with Gage R&Rs, validations, and fixturing.
• Experience using lab or digital measuring equipment (e.g. microscopes or Keyence).
• Strong knowledge and familiarity with GMP & GDP practices.
• Ability to perform complex and technical troubleshooting.
• Attention to details.
• Familiarity with Excel Macro design and GAMP (Good Automation Manufacturing Practice) compliance.
• Good computer skills, including usage of MS Office Suite.

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 $51,000 to $72,000 (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 complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.