23 month Fixed Term Contract
Position Summary
The Staff Project Engineer will provide technical leadership across various project related activities. A knowledge of the design, development, and validation of manufacturing technologies 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 Areas of Responsibility
* Provide engineering leadership for new equipment and process changes, ensuring that all activities are completed and documented in accordance with regulatory requirements.
* Technically lead the introduction of new capital equipment and lead 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 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.
* Own budgetary, scheduling, and project databases, and report regularly to 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.
* Develop 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 lead 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.
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.
* Has 3-5 years’ experience in a manufacturing environment.
* Strong communication and influencing skills with both internal and external agents.
* Capable of technical leading, influencing and providing technical direction to Engineers, Coop Students, Technicians and operators as required.
* Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated 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.
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