Project Engineer, Manufacturing

Project Engineer, Manufacturing

Position Summary

The Project Engineer will provide technical support under supervision 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 with relevant regulatory requirements and medical device standards.

Key Areas of Responsibility

• Under supervision, provide engineering support for new equipment and process changes, ensuring that all activities are completed and documented in accordance with regulatory requirements.
• Under supervision, technically support the introduction of new capital equipment and support the associated qualification and validation activities - VP, IQ, OQ, PQ. Assist with testing for validations where required.
• Under supervision, evaluate process layouts to support new process integration while ensuring optimal utilisation of floor space and 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).
• Under supervision, 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.
• Under supervision, developing specifications in the form of a URS for new equipment purchases.
• Under supervision, support capital acquisition activities.
• Under supervision, 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.
• Demonstrate ownership and integrity of work.
• 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.

Qualifications Knowledge Skills

• Level 8 Degree in Mechanical Engineering or equivalent technical experience is required.
• Proven Project Engineering skills through the delivery of business-critical projects.
• 0+ years of work experience.
• Strong communication and influencing skills with both internal and external agents.
• Under supervision capable of technical leading, influencing and providing technical direction to Co-op Students, Technicians and operators as required.
• Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results-oriented environment.
• Demonstrable analytical & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment.
• Technological pioneer, willing to source, investigate and implement technological and automation advances.
• Confident and effective decision maker, with a proven leadership ability to negotiate and influence others.