Senior Manufacturing Engineer

Department: Research and Development
Reporting: R&D Manager

DESCRIPTION

At Neurent Medical, our Engineers are developing innovative manufacturing solutions both in-house and at suppliers and manufacturing partner sites. We are expanding our Engineering team; we seek a Senior Manufacturing engineer to focus and apply knowledge of technical principles and systems/procedures to optimise manufacturing processes. This is an exciting opportunity to get involved in the highly innovative and rapidly growing world of minimally invasive ENT therapeutic devices, where you will develop the company’s technology and advance our treatment of rhinitis.

DUTIES & RESPONSIBILITIES

The successful candidate will have responsibility for, but is not limited to, the following skillsets:

• Full responsibility for the process development life cycle from ideation through to commercial validation.
• Participate in supplier selection for device manufacture, tooling and components.
• Identify and ensure implementation of opportunities to optimize/improve manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods)
• Employing technical skills to design and ensure equipment, tools, 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.
• Work with internal team members to explore new technologies, assess in terms of performance, cost and reliability.

EDUCATION/EXPERIENCE

• 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