Medical Manufacturing Facility Project Manager

3 weeks ago

Kitchener, Canada FluidAI Medical Full time

**Company Description**:
FluidAI Medical is a medical device organization creating a paradigm shift in post-operative care, utilizing the plethora of data within the body, to help in the detection of post-operative complications at their onset. Our clinically-validated platform sensing technology augments existing wound drains and catheters, providing healthcare providers with a smart monitoring tool that can support earlier detection of deadly complications and enhance the delivery of care. We are an equal opportunity employer and have a diverse team representation across language, ethnicity, gender, and nationality.

**Why join FluidAI?**
- Mission to save lives and improve patient care with technology that is already deployed on patients in real-world settings.
- Work with a high-performing and cross-functional team that is empowered to grow, learn, and contribute across all levels of the organization.
- Personal career-focused development and training with access to workshops, coursework, and experienced mentors/consultants.
- Health and wellbeing benefits, including vision, drugs, dental, and life insurance.
- Regular offsite activities - past events include rafting, axe-throwing, sports leagues, and the usual BBQ.
- WFH/WFO flexible hybrid model.
- Unlimited vacation and paid parental leave.

**Job Summary**:
FluidAI is current expanding its sales operations into the middle east where Saudi Arabia is at the core of this expansion. Our team is engaging a manufacturing partner on Saudi soil to lead production needs in the middle eastern markets. Early production steps in this manufacturing line will be executed on Candian soil while the remaining steps are executed in the Saudi facility. Your role will be to lead these integration efforts to create a seamless partnership with the highest standards of quality and process.

You will work with a high performing cross-functional team interfacing with product development, manufacturing, and quality assurance functions at various stages, including product development, product realization, and post-market surveillance. It's not everyday that you get a chance to make a direct impact on people's health. If you're looking to join a strong team advancing a meaningful product, this is for you

**Responsibilities**:
As a Project Manager, you will be spear-heading the effort of bringing this prospective production line to reality, which will include the following responsibilities:

- Accountable for the successful execution of all assigned projects, where success includes on-time on-budget, high quality/compliant project results
- Identify and resolve risks and issues to meet project deadlines
- Lead a team of internal and outsourced developers and vendors
- Acting as the first point of contact with our Saudi partner during the project setup phase
- Hiring the right personnel on both the Canadian and Saudi soils to support the bring up of the project (e.g. Production Technicians, Manufacturing Quality Engineers, Manufacturing Engineers, Production Managers, Supply Chain Managers, etc.)
- Replicating parts of the existing production line on the Canadian soil in a separate facility
- Supervising the set up efforts of the production line in the Saudi facility and coordinating with the vendors and service providers (production equipment and tooling purchase and setup, construction modification, etc.)
- Supervise the acquisition of required licensing from the Saudi and Canadian authorities
- Finding alternative raw material suppliers in the Saudi market for the production steps executed in the Saudi facility
- Ensure compliance with ISO 13485 standard
- Provide recommendations for improving the efficiency of the production line (cost and time)

**Qualifications**:

- Minimum 5 years progressive clinical Project Coordinator/Manager experience in medical devices
- Good knowledge of the medical device development process ISO 13485
- Experience in product development in the medical device industry
- Demonstrated experience in leading projects and managing vendors and service providers
- Excellent English and Arabic communication skills, both oral and written
- Proficiency in using general office productivity software (e.g. Microsoft Office, etc) for communication and documentation purposes.

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