Job Description

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:
Associate’s Degree or equivalent in or equivalent technical certificate , 2 years years experience of previous experience in manufacturing and/or medical device experience Required or
4 years years experience of related experience Required

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 EHS rules and requirements 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

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