Project Manager

Medica manufactures and develops a line of easy-to-use and maintain, low-cost blood testing analyzers for clinical laboratories.  The Company’s growth is a result of its strategic focus on the worldwide need to lower healthcare costs.

The R&D Project Manager reports to the director of Hematology. This position is responsible for the project management of one or more development and support projects. The project manager is expected to provide regular project updates, drive timelines, and champion the product development process for Medica’s IVD products. The specific project for this hire is a point-of-care microfluidic and imaging-based diagnostic analyzer for CBC with 5-part differential. This development effort, as with Medica’s others, is multi-disciplinary including: mechanical, electrical, chemistry and software.

Job duties:

• Develop and maintain project plans using agile and waterfall tools in Jira.
  • Track and maintain weekly deliverables.
  • Weekly updates to critical path tracking for next major milestone.
  • Arbitrate resource priorities.
  • Lead project update meetings.
• Scrum Master (desirable, not essential).
• Manage/Administer regulatory requirements through the product development process.
  • DHF filings
  • Track project risks.
  • Write/maintain specifications (in collaboration with marketing)
  • Maintain traceability documentation.
  • Lead/Administer risk analysis.
  • Lead/Administer FMEA
  • Primary interface to FDA for pre-submissions
  • Creation and maintenance of software Plan (Ideally have experience with ISO 14971)
    • software development plan
    • Documentation,
    • Cybersecurity Plan
    • Risk Analysis.
• Lead/Administer phase ending design reviews.
• R&D Administration
  • Generate project budgets, summaries of project spending, and resource allocation, as needed.
  • Manage PLM tools.
• Assist in transfer to manufacturing.

Desirable Skills/Background:

• Bachelor’s degree in science or engineering
• Prior experience as a Project Manager or Program Manager
• Experience in Medical Devices, particularly IVD, preferred.
• Familiarity with FDA and IVDR regulatory requirements and processes.
• A willingness to learn and/or augment knowledge of industry and regulatory standards
• Energetic, hard-working, willing to take on new roles and responsibilities
• Strong verbal and written communication skills
• Experience with MS office applications including Project, strong computer skills
• Experience with Jira for agile and waterfall project management
• Experience as a scrum master (optional, but desirable)

Interested Applicants should forward their resume to:

Mary Williams
VP, Human Resources
Medica Corporation
[email protected]