Process Engineer

Tec Partners

TEC Partners are pleased to have partnered exclusively with an innovative medical device company who have created a pioneering compact and powerful device, with the goal of transforming the treatment of heat stroke. The product is similar to taking an ice bath in a portable form, offering the benefits of immersing in ice water while utilising significantly fewer resources.

There are numerous markets where the product can be effectively deployed. Any scenario where heat or humidity is coupled with strenuous activity, heat stroke poses a viable threat. The products lightweight design enables it to be utilised in any scenario, significantly increasing capacity for successful treatment.

Process Engineer Role:

My client is seeking a skilled and motivated Process Engineer to play a crucial role in establishing a robust production system for our innovative medical device. As a Process Engineer, you will lead the design transfer project, transitioning our prototype technology into a commercially manufactured medical device. Additionally, you will develop, implement, and maintain manufacturing processes while upholding rigorous quality standards. Your responsibilities will encompass quality control method development, validation, and support for continuous improvement initiatives to ensure product excellence. The ideal candidate will have a strong background in process engineering, along with expertise in quality management systems and regulatory requirements in the medical device industry.

Process Engineer Requirements:

• Develop a production system for a new medical device
• Design, implement, and validate production processes
• Conduct process validation (IQ, OQ, PQ) and provide support
• Collaborate with cross-functional teams to improve manufacturing, assembly, and QC processes while ensuring compliance
• Optimize processes for cost reduction and efficiency improvement
• Perform process capability studies, statistical analysis, and validation activities
• Create and maintain process documentation (SOPs, work instructions, flowcharts)
• Offer guidance on Design for Manufacture (DFM) for continuous improvement

Process Engineer Requirements:

• Bachelor’s degree in Engineering or a related field
• 2+ years of experience in process or quality engineering within the medical device industry
• Proficient in process validation (IQ, OQ, PQ)
• Strong knowledge of quality management systems, regulatory requirements, and medical device standards
• Experience with quality tools like FMEA, SPC, and RCA
• Familiarity with statistical analysis, process validation, and problem-solving methodologies
• Excellent analytical, problem-solving, and decision-making skills
• Strong communication and collaboration abilities
• Knowledge of various industrial manufacturing processes
• Preferred certifications: ASQ CQE or Six Sigma

This is an excellent opportunity to join a rapidly growing medical device company who will pave the way within their field in years to come as they continue to go from strength to strength. As such, you will be rewarded with competitive salary options and share options.

If this role is of interest, please apply with an up to date CV