Technologist, Transfer Projects

Edwards Lifesciences Gruppe; Salt Lake City (UT); On-site; USD 75,000 - 105,000; Full time

Job summary

Edwards Lifesciences in Salt Lake City is seeking a Manufacturing Equipment Validation and Maintenance Specialist to support the transfer of new products into manufacturing and ensure equipment readiness for validation and qualification.

You will troubleshoot, perform preventive maintenance, conduct feasibility studies, document actions, and collaborate with Quality, Transfer Engineering, and Operations to sustain regulatory compliance and production uptime.

Qualifications

• H.S. Diploma or equivalent with 6 years related experience or
• Associate's Degree or equivalent with 4 years related experience
• Experience in manufacturing and/or medical device environment preferred
• Strong written and verbal communication and training abilities

Responsibilities

• Troubleshoot and maintain automation and production equipment to minimize downtime.
• Support transfer of new products into manufacturing and ensure readiness for validation.
• Collaborate with Quality, Transfer Engineering, and Operations to implement corrective actions and documentation.
• Ensure adherence to Good Documentation Practices and regulatory requirements.

Skills

Troubleshooting

Preventive maintenance

Root cause analysis

GDP/GMP compliance

Cross-functional collaboration

Documentation practices

MS Office

CAD

Education

High School Diploma or equivalent

Associate's Degree or equivalent

Tools

JDE

QMS

PLM

Maximo

Job description

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, 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.In this role, you will help bring life-changing products to patients by supporting the successful transfer of new products into manufacturing. Working closely with Transfer Engineering, Operations, and cross-functional partners, you'll provide technical expertise to ensure manufacturing readiness and contribute to smooth, successful commercial launches.How you'll make an impact:• Troubleshoot and recommend maintenance to limit downtime, to keep production on schedule, and to ensure ongoing validation compliance.• Design, set-up and execute 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.• Perform both scheduled and unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and avoid program down time.• Check for failures in more complex equipment and processes, and perform corrective actions to affected areas that have down time, including conducting and writing impact assessment reports of incidents.• Collaborate with Quality in devising and implementing corrective actions, exception work orders (EWOs), Equipment Non-conformance Reports (ENCRs), and Out of Tolerance (OOTs).• 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.What you'll need (Required):• H.S. Diploma or equivalent with 6 years related experience or• Associate's Degree or equivalent with 4 years related experienceWhat else we look for (Preferred):• Previous experience in manufacturing and/or medical device experience.• Strong written and verbal communication, interpersonal, and relationship building skills including formulating work instructions and providing guidance and training to lower-level employees with little to no direction.• Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices).• Strong computer skills, including usage of MS Office Suite, manufacturing software (JDE, QMS, PLM, Maximo); and CAD if applicable.• Full knowledge of validation and improvement of automated equipment.• Ability to troubleshoot manufacturing equipment.• Ability to understand the fundamentals of project management; Lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework.• Full knowledge of routine preventive maintenance of production equipment and electrical, mechanical, electronic, pneumatic, and controls.• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.• 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.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.