Senior Technologist, Maintenance Manufacturing Support

Imagine how your ideas and expertise can change a patient’s life. Our Global Supply Chain team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.

The Senior Technologist will provide technical manufacturing support to Operations and Engineering.

How you’ll make an impact:

• SME (Subject Matter Expert) with in-depth knowledge and technical proficiency in asset management, equipment maintenance, and manufacturing support activities.
• Perform software validation (SWV) and installation qualifications (IQ) for equipment and product designs.
• Design, set-up and execute complex feasibility studies, experiments, and tests – both creating and following established protocols to develop findings for the validation and improvement of equipment and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review.
• Lead and manage projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework. Collaborate with Engineering on product/process root cause investigations.
• Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval.
• Utilize manufacturing software (e.g., JDE, QMS, PLM – Windchill) to update documentation in systems (e.g., ECRs, Maximo).
• Collaborate with Engineering and CAD/Designers to develop new complex tools/equipment.
• May source basic new equipment for implementation into manufacturing.
• Provide coaching and guidance to technicians.
• Check for failures in equipment and perform corrective actions to affected areas that have down time, including conducting and writing impact assessment reports of incidents, exception work orders (EWOs), Equipment Non-conformance Reports (ENCRs), and Out of Tolerance (OOTs).
• Troubleshoot, as well as anticipate issues, and propose solutions to limit downtime and keep production on schedule.

What you’ll need:

• H.S. Diploma with equivalent 10 years’ related experience or Associate’s Degree with equivalent 8 years’ experience related experience.
• Experience in manufacturing operations.

What else we look for:

• Medical device industry experience; cleanroom ISO Class 5 and above.
• Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices).
• Extensive knowledge of validation and improvement of automated equipment.
• Extensive knowledge of equipment in a lab/cleanroom environment
• Extensive knowledge of electrical, mechanical, electronic, pneumatic, and controls.
• Ability to use a wider range of manufacturing, test, development or diagnostic equipment; use tools such measuring equipment.
• Ability to troubleshoot manufacturing equipment.
• Knowledge of material compatibility in the proposed use environment.
• Excellent written and verbal communication, interpersonal, and relationship building skills with focus on influencing and conveying recommendations.
• Strong computer skills, including usage of MS Office Suite.
• Ability to understand the fundamentals of project management.
• Must be able to work independently in completing assigned projects, developing work instructions, and advancing the competency of other technicians.

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 $68,000 to $97,000 (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.

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