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Job Details

Senior Technologist, Maintenance & Manufacturing Support

Type

Full time

Category

Manufacturing

Location
USA - California – Irvine
Job reference

Req-49990

Posted for

19 hours ago

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality 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. 

The Senior Technologist, Maintenance and Manufacturing Support role provides technical manufacturing support to Operations and Engineering.

The standard hours for this role are Monday-Friday 8:30am-5pm.

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.
• 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.
• 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.

• Troubleshoot, maintain, and optimize PLC, HMI, and automated control systems to improve equipment reliability and minimize production downtime.
• Collaborate with Engineering and CAD/Designers to develop new complex tools/equipment.
• Perform primarily unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and avoid program down time, including providing expertise and guidance in resolving complex failures.
• 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).

What you'll need:
• H.S. Diploma or equivalent with 10 years related experience required or
• Associate's Degree or equivalent 8 Years years experience related experience required
• Previous experience in manufacturing and/or medical device experience required

What else we look for:
• Excellent written and verbal communication, interpersonal, and relationship building skills with focus on influencing and conveying recommendations.
• Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices).
• Strong computer skills, including usage of MS Office Suite, utilizing manufacturing software (e.g., JDE, QMS, PLM) to update documentation in systems (e.g., ECRs, Blue Mountain); and CAD if applicable.
• Extensive knowledge of routine preventive maintenance of production equipment, validation and improvement of automated equipment, electrical/mechanical/pneumatic controls, and troubleshooting equipment.

• Working knowledge of industrial control systems, including PLC programming, troubleshooting, and diagnostics.

• Experience supporting and modifying Human Machine Interface (HMI) applications used in manufacturing environments.

• Familiarity with industrial communication protocols and networked automation systems.

• Ability to interpret and troubleshoot control system architectures, electrical schematics, and I/O configurations.
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.
• Must be able to work independently in completing assigned projects, developing work instructions, and advancing the competency of other technicians.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

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 $70,000 to $99,000 (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.

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About Edwards Lifesciences

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 Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds.
Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below.