Job Description Summary

Job Description

Key Responsibilities:
• 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. Operate a variety of test equipment to assess characteristics of the manufacturing environment
• Consult with Engineers, Technicians, and Assemblers on processes to execute experiments and/or production runs. Support related to equipment investigations, testing, objective evidence of product dispositions and rework support work necessary.
• 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
• Follow through with development of training and documentation materials, based on collaboration with Engineering, including identifying opportunities for modification and making recommendations, enabling the seamless knowledge transfer of project and manufacturing processes; applying knowledge of processes to devise process changes in collaboration with
• May lead projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework
• Identify potential improvement opportunities and propose solutions to optimize process and/or equipment, e.g., re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, for Engineering review
• Provide coaching and guidance to technicians
• Other incidental duties (e.g. occasional photo copying or deliveries)

Education and Experience:
Other: in Technical degree/certificate in related field , 2 years years experience of previous experience in electronics, electronical, mechanical, or engineering experience Required
Bachelor's Degree in in related field Preferred

Additional Skills:
• Good written and verbal communication, interpersonal, and relationship building skills
• Excellent computer skills, including usage of MS Office Suite
• Ability to read, comprehend, write and speak English
• Substantial knowledge of validation and improvement of automated equipment and procedures
• Ability to perform more complex troubleshooting
• Ability to identify problems and relevant issues in straightforward and more complex situations, assessing using standard procedures
• Ability to use a wider range of manufacturing, test, development or diagnostic equipment; use tools such measuring equipment
• Ability to read and understand procedures, drawings, schematics and carry out assembly instructions
• Substantial knowledge of statistical software
• Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to clean room medical device manufacturing
• Strict attention to detail
• Must be able to work in a team environment, including inter-departmental teams
• Ability to provide feedback in a professional, direct, and tactful manner
• 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

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

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