Project Manager, Medical Device R&D
In this role, reporting to the Senior Project Manager, you'll guide cross-functional initiatives across software, machine learning, optics, electronics, firmware, and mechanical design. You'll bring structure, clarity, and alignment to fast-moving technical teams working on breakthrough innovations.
The person will be responsible for:
- Developing and maintaining integrated project plans, ensuring projects are delivered on time, within scope, and within budget.
- Owning projects execution across the product development lifecycle, including concept development and feasibility assessment, requirements, design, verification & validation, pre-clinical and clinical activities, and manufacturing transfer.
- Driving project scope definition, objectives, key-results, schedules, and success metrics in collaboration with technical and business stakeholders.
- Managing cross-functional teams across Software, Hardware, Systems Engineering, Quality, Regulatory Affairs, and Operations.
- Owning critical path analysis, dependency management, resource planning, and schedule recovery strategies.
- Leading phase-gate reviews (SRR, PDR, CDR, TRR, Design Reviews, etc.) and ensuring readiness criteria are met.
- Maintaining project documentation and records in accordance with company Quality Management System requirements.
- Identifying, assessing, and mitigating project risks, issues, and dependencies, while driving timely resolution of execution challenges.
- Monitoring project performance using appropriate planning and tracking tools, metrics, and reporting mechanisms.
- Driving Agile, Waterfall, or hybrid development methodologies as appropriate for the project and organizational needs.
- Facilitating alignment between technical teams and leadership while maintaining focus on company objectives and product milestones.
Basic Skills and Qualifications
- Bachelor's degree in Engineering, Science, Health Sciences, Business, or a related technical field.
- 3+ years of project management experience.
- Experience working in highly regulated industries such as medical devices, pharmaceuticals, aerospace, automotive, or defense.
- Experience using project management tools such as Jira, MS Project, Confluence, and Microsoft Office.
- Strong understanding of technical documentation, engineering development processes, and product development workflows.
- Strong analytical, organizational, problem-solving, and communication skills.
- Ability to be physically present in the office at least three days per week.
Highly Desired Skills and Qualifications
- PMP, PRINCE2, Agile, or Scrum certification.
- Experience in medical device development and familiarity with design controls, risk management, verification and validation activities, and manufacturing transfer.
- Working knowledge of ISO 13485, FDA Design Controls (21 CFR 820), IEC 62304, ISO 14971, and related medical device development standards.
- Experience leading projects in startup or high-growth technology environments.
- Ability to understand technical requirements, challenge assumptions, and effectively engage with engineering teams on development trade-offs and execution strategies.
- Experience supporting clinical studies, regulatory submissions, or commercialization activities.
- Previous experience managing projects involving both hardware and software development teams.
Anticipated Start Date: As soon as a suitable candidate is found
Duration: Full time Permanent (40 hours per week)
Salary: Commensurate to experience and qualifications
Location: Edmonton, Alberta, Canada (Onsite)
What you can expect from PulseMedica:
- Competitive compensation, group benefits and the option to participate in our employee stock option plan
- Free on-site gym (Jackson's Gym)
- A role that contributes to helping change people's lives by enhancing their vision
- A unique opportunity to build, grow, and be part of a team that is going to revolutionize a multi-billion dollar industry
- Hybrid work
- Growth Opportunities to build a small team
- Monthly team events
We believe that diverse teams perform better and that fostering an inclusive work environment is a key part of growing a successful team. We welcome people of diverse backgrounds, experiences, and perspectives to apply for this position.