Medical Device Project Manager

**Overview**

**Responsibilities**

1. Project Planning and Coordination:

- Develop comprehensive project plans outlining scope, timelines, milestones, resource requirements.
- Coordinate with stakeholders, including R&D, Operations, Key Opinion Leaders (KOLs), Contractors, and Quality Assurance teams, to ensure alignment with plan and project objectives.

2. Team Leadership:

- Identify project goals and direction; set a clear vision and move forward with passion.
- Empower and motivate your project team by clearly setting expectations related to quality and performance and ensure the team works effectively.
- Establish good communication practices with team members including outside vendors.
- Use creative ways to solve problems through use of divergent/convergent thinking when dealing with bottlenecks and project variances.
- Further expand our company’s capability in both project management and product development by introducing new techniques and refining existing techniques
- Make scientifically supported recommendations for promising initiatives most likely to achieve company objectives. Stay informed of current state of the art in relevant scientific and technical areas.

3. Risk Management:

- Identify potential risks and challenges associated with medical device projects and implement mitigation strategies.
- Stay abreast of regulatory changes and industry trends to anticipate potential impacts on project timelines and deliverables.

4. Cross-Functional Collaboration:

- Foster effective communication and collaboration among cross-functional teams to ensure seamless project execution.
- Serve as a liaison between different departments, promoting a cohesive approach to achieving project goals.

5. Resource Management:

- Estimate, allocate, and manage project resources efficiently, including personnel, budget, and materials.
- Monitor and report on resource utilization, identifying opportunities for optimization.

6. Regulatory Compliance:

- Ensure that all medical device projects comply with relevant regulatory standards and guidelines.
- Collaborate with regulatory affairs teams to navigate and address regulatory requirements throughout the project lifecycle.

7. Quality Assurance:

- Understand, comply, and contribute to the Quality system, regulatory requirements, and business practices necessary to complete company goals.
- Implement and uphold quality assurance processes to guarantee the delivery of high-quality medical devices.
- Conduct regular reviews to ensure compliance with quality standards.

8. Project Reporting:

- Generate regular project status reports for senior management and other project stakeholders highlighting key achievements, challenges, and upcoming milestones.
- Communicate project updates to stakeholders and address any concerns or questions.
- Maintain accurate and up to date project data and records.
- Prepare project documentation and ensure compliance with required design control processes.

**Qualifications**
- Bachelor's degree in engineering, project management, or a related field.
- Proven experience (3 years) in project management, specifically within the medical device industry.
- Prior history working in an FDA and/or ISO regulated development environment; specifically, 21 CFR 820 and ISO 13485
- Knowledge of FDA 510(k), PMA, De Novo process, or Clinical Trials strongly preferred.
- Proven ability to collaborate cross-functionally and demonstrate leadership.
- In-depth knowledge of regulatory requirements, quality standards, and project management methodologies.
- Excellent interpersonal, communication, and leadership skills.
- Strong analytical and problem-solving abilities.
- PMP or other relevant project management certifications are a plus.

**Why Work Here**
- Fast-paced environment that encourages self-development and growth.
- We offer an Incentive Stock Options Plan (ISOP), health benefits and professional development opportunities.

**Salary**: From $80,000.00 per year

**Benefits**:

- Dental care
- Paid time off
- Vision care

Schedule:

- Monday to Friday

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- project management: 3 years (preferred)
- medical device industry: 3 years (preferred)

Work Location: Hybrid remote in Halifax, NS B3H 0A8