SUMMARY A senior process development engineer will play a key role in planning , developing , and optimizing manufacturing processes to improve efficiency, quality and cost-effective for production systems, to enhance the speed and quality of processing, and ensure produced items comply with international regulations and industry standards.
This role may coordinate the job of other process and product development engineer and technician, ensuring team members align to the goals providing proper coaching and mentoring.
Requires a deep understanding of process engineering principles, strong analytical skills, and the ability to lead cross-functional teams to implement new projects, products, or process improvements.
Process development engineers use technical knowledge and industry expertise to review existing and new manufacturing production lines and plan cost-effective production processes within a business.
For example, these professionals may use computer modeling software to test how new machinery or technology could improve the speed of production DUTIES AND RESPONSIBILITIES: Develop, evaluate, and improve manufacturing processes to enhance product quality, reduce costs, and increase efficiency.
Analyze new equipment, technology, or machines to implement into the production process, and new products .
Conduct root cause analysis and implement corrective actions for manufacturing line.
Design specifications for product use, create schedules, and execute implementation.
Lead process design, development, and implementation projects from concept through to production.
Utilize statistical process control and other quality tools to assess processes, monitor and improve process performance.
Execute equipment qualification, develop equipment documentation (Protocols, reports, preventive maintenance) Execute process validation activities, develop process validation documentation (Protocols, reports, test methods, ATMV, VTMV) Conduct process characterization and capability studies to process changes.
Develop best practices, routines and innovative solutions to improve production rates and quality of output Perform process simulations Manage cost and time constraints Perform risk assessments Develop and maintain process documentation, including work instructions, BOMs, and standard operation procedures.
Develop quality control criteria and safety guidelines and ensuring that all team members adhere to them.
Performs other related duties as assigned by management.
Supervise and coach professional and technical levels.
Requirements Bachelor's degree in engineering and related fields and a minimum of 7 years of experience in process development, preferably in medical devices industry or highly regulated industries.
Experience with statistical process control and design of experiments.
Postgraduate degree in PM, medical devices, engineering is desirable.
English proficiency (B2, C1 equivalent) Good working knowledge on some or any of the following technologies braiding, reflow, grinding, adhesive bonding, and soldering processes.
Experience in manufacturing and product transfers Experience in equipment qualification, process improvement and process validation Proven abilities to work on collaborative environments and operational excellence.
Excellent problem solving and attention to detail.
Proven capabilities managing teams.
Benefits Highly competitive package