Provide technical manufacturing support to Operations and Engineering.
How you will make an Impact:
• 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
• Collaborate with Engineering on equipment investigations, testing, objective evidence of product dispositions and rework
• Compile documentation for archives to ensure appropriate documentation for development work, including ECRs, SOPs, drawings, and tooling, for Engineering approval
• Utilize manufacturing software (e.g., JDE, QMS,PLM) to update documentation in systems
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• 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
• Troubleshoot basic manufacturing equipment
• Other incidental duties
What You'll Need (Required):
Associate's Degree or equivalent Required or technical degree/certificate in related discipline Required
1 year of related experience Manufacturing and/or medical device experience Preferred
What else we look for (Preferred):
• Good computer skills, including usage of MS Office Suite
• Basic written and verbal communication, interpersonal, and relationship building skills
• 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