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Senior Project Engineer Position
2 weeks ago
We are seeking a highly skilled Project Engineer to provide technical leadership across various project-related activities. As a key member of our team, you will play a critical role in ensuring compliance with relevant regulatory requirements and standards for medical devices.
Key Responsibilities:
- 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 utilization of floor space, ensuring optimum process flow.
- Develop and implement appropriate supporting documentation, SOPs, PFMEA, Control Plans, and process work instructions compliant with current Good Manufacturing Practices (GMP).
- Transfer and implement processes, either from development or from another manufacturing facility.
- Own budgetary, scheduling, and project databases and report regularly on progress as well as on problems that could significantly affect cost or schedule.
- Develop specifications in the form of a URS for new equipment purchases.
- Develop capital acquisition activities.
- Provide technical guidance for 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 scoping, approval, budgeting, specification, execution, qualification, and operational handover as appropriate.
- Observe Quality Management Systems requirements on site at all times.
- Provide out-of-hours support to the business as required by management or as mandated by shutdowns and/or equipment failures.
Qualifications and Skills:
- A 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, Co-op 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 and 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.
