Senior Quality Engineer
Medtronic
Manufacturing Process Engineer
Celestica
full-time
Posted on:
Origin: • 🇮🇪 Ireland
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Create, execute, coordinate, and support the design of experiments, test methods, protocols, specifications, and validation documentation (IQ/OQ/PQ)
- Oversee development and execution of qualification trials and characterization studies
- Oversee and analyze performance of equipment, vision systems and machines, optimizing process parameters to eliminate non-conforming products and improve yield
- Champion and drive continuous improvement for production areas using Process Capability and Lean Six Sigma methodologies
- Manage multiple projects, generate comprehensive project plans, and support project teams to drive completion and alignment with strategic objectives
- Support maintenance and calibration of critical equipment-systems, ensuring compliance and optimized maintenance schedules
- Work with cross-functional teams and external vendors to integrate new products, processes, and technologies; lead technology transfer and implementation
- Design, develop, and implement new manufacturing processes and develop application software and tooling for complex machines and mechanical process steps
- Execute capability studies of machines and process steps using Design of Experiments and statistical methods to maximize utilization, throughput, and capacity
- Solve technical product, process, component, and related problems affecting manufacture and provide manufacturability feedback to product designers
- Serve as Shift Engineer following specified A/B/C/D rotating shifts
Requirements
- Experience using engineering tools and software packages to support automated manufacturing processes
- Proven experience in detailed analysis, modelling, and methodologies to validate manufacturing process and tooling design and specifications
- Experience in creating SOP’s, Control Plans, and performing validation (FAT, SAT, IQ, OQ, PQ)
- Demonstrated ability to effectively communicate manufacturing plans, proposals, and results, and negotiate options at executive management levels
- Analytical and strong problem-solving skills
- Excellent interpersonal and communication skills
- Strong aptitude for report writing and data analytics
- Knowledge of the medical device industry and of 21 CFR (820, 11), ISO13485 an advantage, specifically Change Control and Validation
- Minimum of 4+ years’ experience in a Process Engineering role
- Primary Degree in an Engineering/Science discipline (Bachelor degree)
- Medical Device and/or Automation experience an advantage
- Experience in a highly automated manufacturing environment
- Ability to initiate and lead change, collaborate and create alignment, drive accountability, think critically, and make sound decisions
- Willingness to work shift schedules as specified (rotating shift patterns)
