Manufacturing/ Process Engineer with Validation Experience

Job Challenge:
To develop and set-up the manufacturing process of an orthopaedic device using novel proprietary materials and technology.

Qualifications:
Min 3rd level qualification in any of the following disciplines: Manufacturing, Process, Production or Mechanical Eng & preferably with a quality qualification e.g. C&G Quality Control, or Dip. in Quality.

Min. experience:
The candidate must have a minimum of 5 years “Hands on” experience working in a manufacturing environment. You must also be able to demonstrate experience of transferring products from development to manufacturing with a strong emphasis on process and equipment validations. Knowledge of validation requirements in the medical device industry, which would be similar to that in pharmaceutical or aerospace industry, would be an advantage. In addition experience of developing tooling, jigs and fixture that have been used for process improvements in a manufacturing environment is also a requirement. You will also have experience of drawing packages such as AUOTOCAD and Solidworks or other 3D packages. The candidate should also have experience of working and developing lean manufacturing processes and good knowledge of injection moulding. Experience of automation would be an advantage. Familiarity with medical device regulations and working under an ISO13485 or a related quality/regulatory system would also be a distinct advantage.

Your profile:
In addition to being creative, resourceful and an innovator, the ideal candidate is a self starter with a proven project management track record and is a highly motivated, performance driven “Decision maker”. Ideally you have experience of managing small teams therefore you are an excellent communicator and motivator. The ability to “think outside the box” means you can work on your own initiative while your disciplined approach to problem solving and task completion ensures timely delivery of project milestones. A clean driving licence with own transport is required.

General Duties & Responsibilities:

• Report to the Managing Director or designee
• Complete transfer of products from development to manufacturing.
• Develop & draw tools/fixtures/jigs that will help production and reduce cycle times.
• Work on lean manufacturing techniques to improve cycle times.
• Work on process development activities.
• Complete process validations on manufacturing processes.
• Write validation protocols, conduct validation trials & compile comprehensive validation reports.
• Work to achieve goals and objectives as defined in project plans.
• Is responsible for sourcing and following up with tooling manufacturers.
• Prepare ongoing progress reports on a monthly basis or as requested by MD or designee
• Diligently maintains written records on a daily basis of any tests (lab book)
• Make a commitment to the job to complete projects on time (go the extra mile if necessary)
• Follow project plans in line with company objectives.
• Maintain strict control of and preservation of proprietary and third party intellectual property.
• Liaise with appointed consultant(s) and person(s) with overall responsibility for quality and regulatory affairs for FastForm Research.
• Liaison with toolmakers, Universities, suppliers and commercial organisations when required.
• Use absolute discretion at all times in all communications with third parties.
• Is willing to travel if required for the company

Other tasks include but are not limited to the following and will be reviewed and modified if necessary in line with business objectives and strategies:

• Ensure that development is compliant with the company’s regulatory and quality systems, procedures, documentation, audits, and compliance for CE marking etc.
• Generation and control of documentation for manufacturing processes in line with quality system.
• Responsibility for liaison with manufactures, distributors, hospital & healthcare organisations.