Project Engineer

Independent Solutions

Cork

Our client based in Cork is seeking the following: SUMMARY OF JOB: Lead engineer for manufacturing processes development of for new product introductions. The successful candidate will provide project and technical leadership in cross functional teams to set up new processes to meet challenging project commitments in line with agreed stability metrics. The role will involve collaborating with global R&D teams to develop innovative and cost effective devices and delivering highly stable and effective manufacturing processes. PRINCIPLE RESPONSIBILITIES: 1. Lead NPI development requirements and work with cross functional teams in the Innovation Centre and with the Value Streams. 2. Design, develop and source tools, fixtures, gauges and special equipment for manufacturing processes. Co-ordinate with internal and external partners. 3. Provide design for manufacturing technical input to global design groups to minimise lifecycle cost. 4. Deliver stable manufacturing solutions in line with stability metrics process. 5. Management of R&D test parts and sample requests. 6. Conduct detailed product design reviews. 7. Development of advanced manufacturing processes to lean guidelines. 8. Manage risk management and validation lifecycle for new process or process changes. 9. Management of the Asset Lifecycle for new equipment (URS/RA/IQ/OQ/PQ. 10. Full budget responsibility for project capital and expense spend. 11. Direct PFMEA studies and lead risk assessment effort for overall process. 12. Influence innovative qualification methodologies to apply appropriate statistical and validation techniques based on failure model and overall risk. 13. Develop strategic collaborations across functions, business units and geographic boundaries to achieve effective outcomes over the long-term. 14. Provide timely and accurate reporting on project activities. ESSENTIAL CRITERIA: • Obtained as a minimum a Degree in Mechanical/Production/Manufacturing Engineering and 5 years experience in a medical device or comparable hi-tech environment. • Proven track record in development and Installation of manufacturing processes for New Products or Product Transfer. • Experience using proven problem solving/Root techniques (8D, TRIZ or equivalent. • Demonstrated ability to lead sub teams within a project and give direction to fellow team members, contractors, vendors to complete tasks to a defined timeline. • Self motivated, with focus on Quality, Timelines and Cost. • Proficiency of GD&T and ASME Y14.5M 1994 standards. • Excellent Planning & Organizing Skills. • Expert knowledge of lean manufacturing processes. DESIRABLE CRITERIA: • Certified Six Sigma qualifications. • Certified Project Management qualifications. • CAD/CAM Experience. Other Skills, Experience and Education. • Leadership skills. • Proven technical skills. • Ability to organise medium complexity technical issues. • Ability to work effectively in a changing environment. • Knowledge of safety standards. • Knowledge of equipment and process validation and documentation procedures and processes. • Excellent communication and presentation skills. • Results orientated, completes tasks. • Conscientious, self-directed and motivated. • Proven problem solver. • Organised and results orientated. • Ability to take ownership. • Develop good working relationships across the business. • Ability to motivate and lead - must be team orientated. • Honest, open, flexible approach Methodology/Certification Requirements. • Relevant Engineering Degree or equivalent experience. • Minimum of 1 years experience in a technical position. • Technical leadership. • Advanced technical degree. • Prior experience in a GMP or medical device manufacturing environment. • Prior experience in equipment and process validation activities. • Process development experience. • Equipment conceptual skills. • Experience of bespoke capital equipment. This job originally appeared on RecruitIreland.com.

2761 days ago