Location: This position will be onsite but offers flexibility in work location and can be based at one of our Edwards Lifesciences sites either in Irvine, CA, Draper, UT, Ireland, Spain (Valencia), or Singapore.
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 Engineer, Global Validation position is a unique career opportunity that could be your next step towards an exciting future.
We are seeking a highly skilled Senior Validation Engineer to join our Global Validation team within the Worldwide Engineering organization. This role is pivotal characterizing, optimizing, and validating complex manufacturing equipment and processes, leading cross-functional initiatives, and advancing cutting-edge manufacturing technologies.
How you will make an impact:
* Lead validation projects using lean strategies and project management tools (e.g., Gantt charts, risk analysis).
* Drive cross-functional collaboration to meet project milestones and ensure stakeholder alignment.
* Identify and implement process improvements using Six Sigma, Lean, and technical design methodologies.
* Design and execute complex experiments and validation protocols, analyze data, and generate reports.
* Develop and execute validation protocols (CQ, IQ, OQ, PQ, TMV, software validation).
* Conduct engineering studies to assess process variability and define acceptance criteria.
* Manage software/hardware validation with traceability to user/system requirements.
* Recommend and implement enhancements to validation systems for improved compliance and efficiency.
* Train and mentor engineers and technicians on validation best practices.
* Maintain and update training materials and production documentation.
What you’ll need (Required):
* Bachelor’s in engineering or scientific disciplines with at least 4 years of relevant experience; or
* Master’s in engineering or scientific disciplines with at least 3 years of relevant experience; or
* Ph.D. in engineering or scientific disciplines with no experience.
* Experience with validations (i.e. process, equipment, or facility validations)
* Experience working in a highly regulated industry
What else we look for (Preferred):
* Medical device, biotechnology, or pharma industry experience
* Expertise in process validation, equipment qualification, and regulatory compliance.
* Experience with digital validation platforms (e.g., Kneat, Veeva, Valgenesis, or JAMA).
* Familiarity with process automation, measurement system analysis (MSA), and advanced manufacturing technologies.
* Strong knowledge of cGMP, medical device regulations, EHS, and cleanroom manufacturing standards.
* Proficiency in statistical tools (e.g., Minitab) and technical writing.
* Strong analytical, problem-solving, and communication skills.
* Ability to manage multiple priorities in a fast-paced environment.
* Leadership and change management experience.
* Certifications: Six Sigma, CQE, or equivalent.
* Proficiency in MS Office Suite (including MS Project).
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 $106,000 to $149,000 (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.
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