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

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