Sr Tech, Maintenance/Manufacturing Support Eng
Type
Full time
Location
Job reference
Req-39690
Posted for
6 days ago
Provide technical manufacturing support to Operations and Engineering.
Key Responsibilities:
• Perform weekly preventive maintenance routines for equipment to avoid program down time
• 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
• Execute experiments and tests (following 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
• 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
• Identify potential improvement opportunities and propose solutions to optimize equipment, e.g., re-design/design of basic equipment, tools, fixtures, for Engineering review
• Troubleshoot basic manufacturing equipment
• May lead small projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework
• Utilize manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems
• Provide coaching and guidance to technicians
• Other incidental duties
Education and Experience:
H.S. Diploma or equivalent 4 years years experience related experience Required or
Associate's Degree or equivalent 2 Years years experience related experience Required
previous experience in manufacturing and/or medical device experience Preferred
Additional Skills:
• Good written and verbal communication, interpersonal, and relationship building skills
• Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices)
• Good computer skills, including usage of MS Office Suite
• Moderate knowledge of validation and improvement of automated equipment
• Ability to troubleshoot manufacturing equipment
• Basic knowledge of material compatibility in the proposed use environment
• Moderate knowledge of routine preventive maintenance of production equipment
• Moderate 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 under limited supervision
• 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
Avviso importante per i candidati
Obbligo di vaccinazione contro il COVID
Edwards si impegna a rispettare i requisiti e le indicazioni delle pubbliche autorità, oltre a proteggere sia i nostri pazienti vulnerabili, sia gli operatori sanitari che se ne prendono cura in tutto il mondo. Proprio per questo richiediamo la vaccinazione contro il COVID-19 per tutte le posizioni che prevedono un’interazione con il sistema sanitario, ovvero per tutte le persone che nello svolgimento della loro mansione si interfacciano direttamente con i pazienti e quelle che interagiscono con gli operatori sanitari. L’assunzione è subordinata alla presentazione di una prova di vaccinazione completa contro il COVID-19 o di un esonero dalla vaccinazione per motivazioni mediche o religiose legittime. L’obbligo di vaccinazione non si applica nei Paesi in cui la legge vieta di imporre la vaccinazione. Nei Paesi con problemi di disponibilità dei vaccini, o che impongono altri requisiti, possiamo adottare misure alternative che ottimizzano la sicurezza dei pazienti e degli operatori sanitari, come test regolari per il COVID o requisiti specifici in materia di mascherine.
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