Manufacturing Engineer:
The successful candidate will maximize the performance (quality, output volume, & cost) of manufacturing processes within GMIL, by providing high impact technical/operational support, and by developing processes to the highest possible standards.
They will co-ordinate and complete Kaizen activities and development of technicians with a mindset of improvement.
The Manufacturing Engineer will be responsible for providing engineering support to manufacturing, the development of existing and new process technologies.
Job Description:
Role & Responsibilities:
• To implement appropriate process controls on to GMIL manufacturing processes for robust and repeatable commercial product manufacturing.
• Responsible for driving yield, availability and throughput improvement in CER.
• To maximise manufacturing process performance through effective implementation of Lean Sigma methodology.
• To apply a scientific approach to problem solving, combining analytical and experimental skills to maximise overall equipment effectiveness.
• To ensure that all Engineering work and designs are carried out to appropriate GMP, QA/Regulatory Authority standards and Environmental Health and Safety standards.
• To support the development of new processes in conjunction with Process/Manufacturing/R&D Engineering ensuring that new processes are stable and capable.
• To provide technical support to new product/technology introductions.
• To support the development of in-house Subject Matter Experts (SME) across the range of core technologies.
• To ensure that non-conforming products and processes are evaluated and corrected on assigned projects in accordance with process controls and procedures.
• To execute Validation activities as required in conjunction with the validation dept.
• To provide direction and guidance to technician team for assigned CER.
Knowledge & Skills Required:
• Excellent working knowledge of Microsoft Office Packages including Word, Access, Excel.
• Catheter assembly experience a definite advantage.
• Excellent Communication (both verbal and written) & interpersonal skills.
• Experience with team work and proven ability working with other functional roles.
• Excellent understanding of problem solving methodologies is required.
• Flexible, highly motivated individual, positive 'can - do' attitude and a proven track record in team leadership.
• Demonstrate a practical understanding of lean manufacturing principles and statistics
• Some level of people management experience is desirable.
Qualifications and Education Requirements:
• Level 8 Degree in an Engineering discipline or equivalent.
• A minimum of 5 years of professional experience in a responsible Manufacturing Engineering/ Process Development role within Medical Device/Healthcare or similar type industry.
• Proven Implementation of Lean Manufacturing experience essential.
Six Sigma Green or Black Belt qualification is highly desirable and will have a significant advantage.