As Process Development Engineer, you will be responsible for providing engineering support in the creation and the development of new medical device products.
This is a long term hourly rate contract opportunity, close to Cork City.
Job Responsibilities:
- Working as part of the Process Development group this person will aid design of new equipment for new products & manufacturing.
- Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
- Conducts feasibility studies to verify capability and functionality.
- Develops new concepts from initial design to market release.
- Maintains detailed documentation throughout all phases of development.
- Experience with working with Laser Systems & Laser materials processing (Welding, Marking, Cutting, etc) an advantage.
- Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
- Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
- Plans, organizes, and conducts all aspects of technical reviews.
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM's, Routers, FMEA's, etc.).
- Demonstrates strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes.
- Demonstrates strong knowledge and application of Process and equipment validation techniques (IQ, OQ, PQ), PFMEA's, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.
- Co-ordinates execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results.
Skills, Attributes & Experience:
- Bachelor's or Masters degree in Engineering, Science or related discipline.
- 4+years experience in a similar role within a manufacturing environment, Pharmaceutical or Medical Device experience is preferred.
- Understanding of product lifecycle and previous experience in validation requirements for a new product introduction will be an added advantage.
- Excellent communication and analytical skills with the ability to work within a collaborative team environment.
- Proven ability to multi-task and handle tasks with competing priorities effectively.
- Strong technical aptitude and problem solving abilities.
- Cork based role with 5 days a week onsite requirements.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
