Work Flexibility: Onsite Role: 23 Month Fixed Term Contract + full suite of benefits Location: Raheen Business Park, Limerick Work Type: Onsite About Stryker: We are excited to be named one of the World's Best Workplaces by Fortune Magazine!
We are proud to offer you our comprehensive rewards package, including bonuses, healthcare benefits, insurance, retirement programs, wellness initiatives, and service recognition.
Position Overview: The Senior Project Engineer will provide technical support across various project-related activities.
Knowledge of the design, development, and validation of manufacturing technologies is essential for the role, particularly in one or more of the following areas: CNC machining, metrology, packaging, biomaterial production, and coatings.
This role will assess and implement equipment and process changes to the current manufacturing lines, ensuring compliance of Stryker's products in accordance with relevant regulatory requirements and standards for medical devices.
Key Responsibilities: • Provide engineering support for new equipment and process changes, ensuring that all activities are completed and documented in accordance with regulatory requirements.
• Technically support the introduction of new capital equipment and support the associated qualification and validation activities - VP, IQ, OQ, PQ.
• Evaluate process layouts in terms of supporting new process integration while ensuring best utilisation of floor space and ensuring optimum process flow.
• Development and implementation of appropriate supporting documentation, SOPs, PFMEA, Control Plans and process work instructions compliant with current Good Manufacturing Practices (GMP) • Transferring and implementing processes, either from development or from another manufacturing facility.
• Support budgetary, scheduling, and project databases, and report regularly to the project manager on progress as well as on problems that could significantly affect cost or schedule.
• Developing specifications in the form of a URS for new equipment purchases.
• Support of ongoing capital acquisition activities.
• Provision of technical guidance for the maintenance technicians and other engineers on the team.
• Conduct MSA studies for products and new processes.
• Responsibility as technical support for projects (value stream and cross-functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification and operational handover as appropriate.
• Observing the Quality Management Systems requirements on site at all times • Provision of out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures.
• All other duties as assigned.
Minimum Qualifications, Knowledge