Senior Project Engineer

Posted 3 Days Ago
Be an Early Applicant
Limerick
In-Office
Mid level
Healthtech
The Role
The Senior Project Engineer supports project activities, ensures regulatory compliance for manufacturing, and implements process changes.
Summary Generated by Built In
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 & 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.
•    Minimum 2 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-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.

#IJ

Travel Percentage: 10%

Top Skills

Biomaterial Production
Cnc Machining
Coatings
Metrology
Packaging
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The Company
HQ: Irvine, CA
956 Employees

What We Do

Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.

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