Sr. Process Engineer

Pay Rate Range: $45.00 - $55.17 per hour, depending on experience

Responsibilities:

• Responsible for supporting product developments within the TB IDdx Automation development team by managing the establishment of appropriate manufacturing capability and control within the Company group facilities or eternally with key suppliers.
• Provide technical input on the process and production elements of new product developments in line with the key process and business challenges. Critical to Process parameters and validation approach identified during early phases.
• Responsible for ensuring that appropriate best practice is implemented. They will co-ordinate transfer to the contract manufacturer and ensure that process validations are completed as per the validation plan.
• Provide understanding of an appropriate range of production and assembly processes and materials.
• Engage with suppliers to ensure appropriate processes and controls are in place to ensure robust supply and quality.
• Ensure appropriate design outputs are generated throughout the development cycle at appropriate timepoints to ensure manufacturing teams can develop the appropriate documentation, set up appropriate processes and achieve successful validation in alignment with the project schedule.
• Process Key Technical Challenges (KTC) and Critical to Quality (CTQ) parameters are addressed in development.
• Work with partners to determine budgetary estimates for Cost of Manufacture. Work with Procurement function to ensure partners are appropriately linked to the appropriate supply channels.
• Lead the design transfer to manufacture activities and ensure that the device DMR is compiled and maintained
• Assist with process verification/ validation activities and ensure compliance with the validation plan and regulatory and GMP requirements.

• BS in Engineering or life sciences, Master's degree or higher preferred
• 6+ years of relevant technical experience in establishing and validating manufacturing processes
• Ideally, 6 Sigma trained and proven practitioner
• Must have experience leading and delivering on complex interdepartmental projects
• Understanding of Medical Device requirements and is experienced in regulated QMS environment
• Experience working with FDA-regulated products is strongly preferred
• Demonstrated ability to manage external suppliers and/or technical partners