Our client a high potential and well-funded medical device start-up company are currently seeking a Manufacturing Engineer to join their team. Reporting to a Director of Technical Operations the Manufacturing Engineer will work on aredeveloping innovative manufacturing solutions both in-house and at suppliers and manufacturing partner sites. The Manufacturing Engineer will also focus andapply knowledge of technical principles and systems/procedures to optimise manufacturing processes.


Role/Responsibilities

• Full responsibility for the process development life cycle from ideation through to commercial validation.
• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods)
• Deploy the principles of KPI analysis, lean and six sigma in identifying and implementing the optimum areas for improvement in manufacturing operations
• Work with internal team members to explore new technologies, assess in terms of performance, cost and reliability.
• Employing technical skills to design and ensure equipment, tooling, fixtures, etc are up to standards.
• Develop state-of-the-art understanding of relevant products and processes.
• Develop and maintain operational processes and procedures incorporating industry best practices and in compliance with appropriate regulatory requirements.
• Plan and track elements of product development, new product introductions and technology transfers, ensuring adherence to project timelines.
• 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.
• Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
• Proactively identify areas where process and product improvements can be effected.
• Develop predictive engineering tools, techniques and approaches in order to enhance operational processes.

• Degree level 8 in Engineering or related discipline with 5 years + relevant experience – additional relevant qualifications may be advantageous.
• 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 understanding of ISO 13485 and FDA design and development processes.
• Experience with statistical techniques (DOE, Six Sigma).
• Experience working with medical device lab/industrial equipment required.
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
• Good communication and presentation skills are desirable.
• Thinks critically and makes sound decisions.
• Collaborates and creates alignment as a team member/leader.
• Experience and knowledge in Inventing, designing, optimizing verifying methodologies.
• Knowledge of regulatory standards and design control systems desirable but not essential.

• Collaborates and creates alignment as a team member