Technol, Maint/Mfg Support Eng (2nd Shift)

Edwards Lifesciences Gruppe; Draper (KY); On-site; USD 60,000 - 90,000; Full time

Job summary

Edwards Lifesciences seeks a hands-on maintenance and validation specialist to support equipment reliability and process improvements in a manufacturing setting in Kentucky. You will troubleshoot, perform preventive maintenance, and lead validation projects while ensuring compliance with GDP and quality standards.

The role requires strong documentation skills, collaboration with Quality and Engineering, and effective communication to drive continuous improvement in a medical device environment.

Qualifications

• High school diploma or equivalent with related experience; or an associate degree with related experience.
• Prior manufacturing and/or medical device experience preferred.
• Strong troubleshooting and problem-solving abilities; good documentation practices (GDP).
• Proficient with MS Office; CAD experience beneficial.

Responsibilities

• Troubleshoot and perform maintenance to minimize downtime and support validation.
• Design, set-up and execute feasibility studies and tests for equipment validation and process improvement.
• Lead projects on equipment validation and investigations; document findings and dispositions.
• Perform preventive maintenance on a range of equipment; validate operation and reduce downtime.
• Investigate failures and write impact assessment reports; implement corrective actions.
• Collaborate with Quality on corrective actions, EWOs, ENCRs, and OOTs.
• Review and move documentation to appropriate locations (ECRs, SOPs, drawings, tooling).
• Update documentation in systems using manufacturing software (JDE, QMS, PLM).
• Collaborate with Engineering to develop new basic tools; provide coaching to technicians.

Education

HS Diploma

Associate's Degree

Manufacturing/medical device experience

Troubleshooting

Documentation & GDP

MS Office

CAD (basic)

Tools

JDE

QMS

PLM

CAD software

Job description

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 Technol position is a unique career opportunity that could be your next step towards an exciting future.

Key Responsibilities:

• 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
• Lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework
• 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
• Utilize manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems
• Collaborate with Engineering and CAD/Designers to develop new basic tools
• Provide coaching and guidance to technicians
• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period
• Other incidental duties (e.g. occasional photo copying or deliveries)

Education and Experience:

• H.S. Diploma or equivalent 6 Years years experience related experience Required or
• Associate's Degree or equivalent 4 Years years experience related experience Required
• previous experience in manufacturing and/or medical device experience Preferred

Additional Skills:

• Strong written and verbal communication, interpersonal, and relationship building skills
• Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices)
• Strong computer skills, including usage of MS Office Suite; and CAD if applicable
• Full knowledge of validation and improvement of automated equipment
• Ability to troubleshoot manufacturing equipment
• Knowledge of material compatibility in the proposed use environment
• Ability to understand the fundamentals of project management
• Full knowledge of routine preventive maintenance of production equipment
• Full knowledge electrical, mechanical, electronic, pneumatic, and controls
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Strict attention to detail
• Must be able to work with other departments including formulating work instructions and providing guidance and training to lower-level employees with little to no direction
• 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.