Job Description

Job Summary

We are seeking an experienced Project Manager to lead cross-functional software development projects within the medical device industry. The ideal candidate has a strong background in software lifecycle management, regulated product development (ISO 13485, IEC 62304, FDA 21 CFR Part 820), and collaborative leadership across engineering, quality, and regulatory teams.

This role will ensure projects are delivered on time, within scope, and compliant with all applicable quality and regulatory standards, driving innovation and excellence in our medical technology solutions.

Lead end-to-end project management for software components of medical devices--from concept through design, verification/validation, and product release. Develop and maintain comprehensive project plans, including timelines, budgets, and resource allocations. Manage project scope, risks, and dependencies to ensure successful outcomes. Coordinate cross-functional teams (software, hardware, QA/RA, clinical, manufacturing) to ensure alignment and timely deliverables. Serve as the primary communication point for project status, milestones, and issues to senior management and stakeholders. Ensure compliance with medical device regulations and quality management systems (QMS), including ISO 13485, IEC 62304, and FDA Design Control requirements. Facilitate design reviews, risk assessments (ISO 14971), and project documentation. Apply Agile or hybrid project management methodologies suitable for regulated environments. Drive continuous improvement in project execution and delivery processes.

Qualifications

Education:

Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or related field (Master's preferred).

Experience:

5+ years of project management experience, including at least 3 years in software development. Proven experience managing projects in the medical device industry or other regulated environments. Strong understanding of software development lifecycles (Agile/Scrum, Waterfall, or hybrid). Familiarity with regulatory submissions (FDA, CE, Health Canada) is an asset. PMP, PRINCE2, or Agile certification (e.g., CSM, PMI-ACP) preferred.

Skills:

Excellent leadership, communication, and organizational skills. Ability to manage multiple projects and priorities simultaneously. Strong analytical and problem-solving skills. Proficient in project management tools such as Jira, MS Project, Smartsheet, or equivalent. Detail-oriented with a commitment to documentation and compliance.
Job Type: Fixed term contract
Contract length: 6 months

Pay: $70.00-$80.00 per hour

Expected hours: 40 per week

Work Location: Hybrid remote in Grimsby, ON L3M 5E2