Technol, Maintenance (2nd Shift)

Innovation starts from the heart. Edwards Lifesciencesis the leading global structural heart innovation company driven by a passion to improve patient 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 Technol position is a unique career opportunity that could be your next step towards an exciting future.

Provides technical and function-specific knowledge to support Operations and Engineering activities.

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 QMSPLM) 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 related experience Required or
Associates Degree or equivalent 4 Years 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.