Our client a high potential medical device start up is actively seeking a Senior Manufacturing Engineer to join their expanding engineering team. Reporting to Operations Manager the Senior Manufacturing Engineer will be integral to optimizing, supporting, and advancing manufacturing processes through the application of technical expertise and Lean principles.This is an exciting time to join this comapny as they transistion from an R&D focused organisation into a more operational one. The Senior Manaufacturing ENgineer will work on setting up new manufacturign lines as they bring these processes in house



Role/Responsibilities:

• Collaborating with other engineers and production teams to develop and improve manufacturing processes
• Develop and implement manufacturing systems and strategies to achieve cost, quality, and time objectives.
• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes using Lean methodologies as this is an integral part of the role
• Apply structured problem-solving techniques to process, material or equipment issues while offering manufacturing or quality ideas from experience.
• Develop and maintain operational processes and procedures incorporating industry best practices and in compliance with appropriate regulatory requirements.
• Perform process analysis and identify areas for improvement, recommending and implementing solutions to enhance productivity and efficiency.
• Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyse results, make recommendations, and develop reports.
• Analyse and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
• Work with internal team members to explore new technologies, assess in terms of performance, cost and reliability.

• Degree level 8 in Engineering or related discipline with 5 years + relevant experience – additional relevant qualifications may be advantageous.
• Green Belt certification is a distinct advantage
• Experienced with medical device process and manufacturing development and project/program management, risk analysis and problem-solving skills.
• Knowledge of design verification and process validations, particularly as it pertains to equipment and manufacturing processes.
• Dynamic team player and can work effectively and proactively on cross-functional teams.
• Excellent organisational and interpersonal skills, a team player, proactive and likes to take ownership of tasks/ projects
• Good understanding of lean principles and methodology. (eg., DMAIC, Kaizen, Value Stream Mapping)
• Excellent understanding of ISO 13485 and FDA processes.
• Experience with statistical techniques (DOE, Six Sigma).
• Proficiency with engineering software (e.g., AutoCAD, SolidWorks)