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The Role
Reporting to the Senior Process & Technology Engineer, the Process & Technology Engineer is primarily responsible for supporting day-to-day production within the Biotools manufacturing areas and effectively implementing change management projects.
Duties:
1. Lead Process/Product Validations within the department as they arise, in conjunction with Quality/Validation/Operations groups. Prepare associated protocols, develop and execute plans, and compile relevant reports as required.
2. Provide day-to-day technical support for processing issues or changes on existing manufacturing processes. Lead and coordinate troubleshooting of various manufacturing process issues using Root Cause Analysis methodology, and implement robust corrective and preventative actions.
3. Lead investigations into process, product, and quality issues to achieve long-term solutions. This includes technical support and contact with external personnel and customers on process and product lines.
4. Maintain and develop manufacturing process documentation and procedures. All process changes and modifications should be documented and tracked closely.
5. Ensure compliance with GMP and safety requirements on new and existing equipment.
6. Lead and coordinate risk mitigation initiatives such as FMEA and risk assessments. Identify and develop a risk-based approach to change management in conjunction with validation and QA groups.
7. Conduct feasibility trials/process DOE’s to determine appropriate and robust process windows.
8. Working knowledge of the following would be an advantage but not a requirement: automated/semi-automated assembly equipment, injection moulding and mould tools, high precision punch & die sets, heat sealing, ultrasonic welding, leak testing, vision systems, OEE line performance methodology, Minitab/Lean Six Sigma techniques, AutoCAD.
Who You Are
* Bachelor’s degree in Mechanical/BioMedical/Process Engineering or similar.
* 3+ years relevant experience, preferably within the Medical Device industry or other regulated environments.
* Working knowledge of product & process validations essential.
* Excellent verbal, written, and interpersonal communication skills.
* Process-driven and experienced in standardizing and simplifying work processes.
* Leadership & influencing skills.
* Excellent engineering ability.
* Good stakeholder management skills across all levels.
* Experience working in a complex matrix organization.
* Team-oriented.
* Demonstrate a high level of responsiveness to internal customers (e.g., production).
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