IVD Product Development Project Leader

Meridian Bioscience International Limited; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

Meridian Bioscience International Limited is seeking a Project Manager to lead cross-functional new product development projects for IVD assays and diagnostic instrument systems in an FDA-regulated medical device environment. You will own project planning, scheduling, risk, resources and budget from concept through launch, with design control compliance and clear decision making.

You will partner with R&D, Regulatory Affairs, Quality, Clinical Affairs, Operations, Marketing and external

Qualifications

• Bachelor’s degree in science, engineering or business required; advanced degree preferred.
• At least 5 years of project management experience leading cross-functional product development projects.
• Direct experience managing FDA-regulated medical device product development projects.
• Working knowledge of medical device design control requirements and product development processes.
• Preferred: Experience with in vitro diagnostic (IVD) products, including assay and/or diagnostic instrument development.
• Preferred: Experience working within Quality Management Systems compliant with FDA 21 CFR Part 820 and applicable medical device regulations.
• Preferred: Project management qualification (PMP) or equivalent.
• Demonstrated Project Management skills with proven record of practical project management experience preferably in the diagnostic or related biotechnical field
• Must have the ability to perform critical path identification
• Excellent problem-solving skills and ability to prioritize multiple projects.

Responsibilities

• Define project scope, goals and deliverables with cross-functional teams.
• Develop accurate project plans and timelines and communicate with leadership.
• Drive team ownership and adjust plans to meet outputs.
• Track project performance and milestones across short- and long-term goals.
• Ensure on-time completion in line with procedures.
• Facilitate cross-functional project team meetings.
• Other duties as assigned.

Skills

Project management

Cross-functional collaboration

FDA-regulated medical devices

Design control

Risk management

Timeline planning

Education

Bachelor’s degree in science/engineering or business

Advanced degree preferred

Job description

Meridian Bioscience International Limited is seeking a Project Manager to lead cross-functional new product development projects for IVD assays and diagnostic instrument systems in an FDA-regulated medical device environment. You will own project planning, scheduling, risk, resources and budget from concept through launch, with design control compliance and clear decision making.

You will partner with R&D, Regulatory Affairs, Quality, Clinical Affairs, Operations, Marketing and external