Senior Project Engineer

CPL

CORK

SUMMARY OF JOB: Development and installation of manufacturing processes and for new product introductions. The successful candidate will provide the technical lead 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. Design, develop and source tools, fixtures, gauges and special equipment for manufacturing processes. Co-ordinate with internal and external partners. 2. Lead NPI development requirements and work with cross functional teams in the Innovation Centre and with the Value Streams. 3. Provide design for manufacturing technical input to global design groups to minimise lifecycle cost. 4. Project planning to deliver project(s) against agreed milestones and project scope (schedule, resource, cost. 5. Deliver stable manufacturing solutions in line with stability metrics process. 6. Management of R&D test parts and sample requests. 7. Conduct detailed product design reviews. 8. Development of advanced manufacturing processes to lean guidelines. 9. Manage risk management and validation lifecycle for new process or process changes. 10. Management of the Asset Lifecycle for new equipment (URS/RA/IQ/OQ/PQ. 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. 15. All other duties as directed by direct manager. ESSENTIAL CRITERIA: Obtained as a minimum a Degree in Mechanical/Production/Manufacturing Engineering and 3 years minimium (Ideally 5 years plus) experience in a medical device or comparable hi-tech environment. Proven track record in development, Installation and qualificatino 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. Skilled in preparing documentation such as project plans, schedules / timelines, checklists, protocols, and reports that are often detailed and complex. Self motivated, with focus on Quality, Timelines and Cost. Proficiency of GD&T and ASME Y14.5M 1994 standards. Excellent Planning & Organizing Skills. Flexible work ethic. DESIRABLE CRITERIA: 1. Certification from an accredited institution in Project/Program Management. 2. Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDD and FDA CFR 820) and other pertinent Design Control requirements. 3. Knowledge of anatomy and physiology. 4. Knowledge of manufacturing processes. THIS JOB DESCRIPTION IS NOT AN EXHAUSTIVE LIST OF THE JOB HOLDERS RESPONSIBILITIES. Actual End Date. 08/03/2020. FTE/volume in % 100. Non Technical Skills and Additional Details. 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 J&J 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. Permanent Salary Equivalent. N/A. Permanent Salary Equivalent Rate. 0.00.

1590 days ago