Automation Engineer
Job Title: Automation Engineer
Department: Operations
Position Summary.
The Automation Engineer will lead the engineering efforts in support of Nuclein’s automation medical device manufacturing strategy. The individual will be responsible for working with automation suppliers to design, deliver, document, qualify and implement a fully functional plastic consumable automation system. Post implementation the position will be responsible for support of manufacturing processes and equipment functionality followed by planned automation expansion. Position will ensure compliance with FDA regulations and cGMP manufacturing and required documentation for a medical device manufacturing solution
Essential Duties and Responsibilities.
· Provide technical leadership for the design, implementation and support of a fully automated plastic consumable system. Function as key interface with automation supplier.
· Support the development and implementation of automation documentation, production processes and equipment procedures such manufacturing instructions/operating procedures, automation workflow development, validations, acceptance protocols, calibration and equipment maintenance
· Develop and support automation specific documentation such as URS, Equipment FEA
· Ensure strict adherence to FDA regulations and GMP guidelines through audits and daily oversight.
· Collaborate with the Quality Assurance and Quality Control teams to address quality issues identified internally as well as supporting field complaints
· Identify and implement facility and equipment needs including oversight of facility design projects and equipment installations and validations to support automation implementation. Will include direct support of implementation of a dry room for assembly. Includes identifying new and/or replacement and spares equipment and processes as well as supporting equipment maintenance.
· Lead product nonconformance and CAPA resolutions. Develop automation performance and quality metric
· Interface with Suppliers to resolve supplier material issues
· Support 3rd Party audits of the manufacturing facility and specifically automation equipment and associated processes and support activities such as calibration and maintenance
· Lead introduction of engineering changes to product to the automation process
· Identify opportunities for process optimization and efficiency improvements.
· Implement lean manufacturing principles to streamline operations and update and maintain product routings and costing information
· Identify and lead continuous improvement projects.
· Promote a safe working environment by enforcing safety protocols.
Education, Qualifications, and/or Experience.
- Bachelor’s degree in engineering, computer science or other relevant technical field.
- At least 5 years of experience in automation development and/or support, preferably in the medical device industry.
- Experience operating in environments of FDA regulations and GMP guidelines is desired
- Excellent problem-solving and decision-making skills.
- Demonstrated ability to drive process improvements and cost reductions.
- Ability to work collaboratively, explain the ‘Why,’ and be able to influence others in a fast-paced environment.
- Ability to operate independently with moderate supervision.
- Ability to work cross-functionally to ensure all manufacturing objectives are met.
- Possess a high level of attention to detail and organization.
- Ability to prioritize tasks and to delegate them when appropriate.
- Proficient with Microsoft Office Suite or related software to complete reports and logs.
- Must be able to traverse the facility.
Physical Requirements.
- Repetitive Motion: Mostly computer use
- Weight Lifting: at least 25 lbs
- Position: Mostly sitting
- Speaking and communicating
- Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas