Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee cross-functional new product development initiatives for in vitro diagnostic (IVD) assays and diagnostic instrument systems within an FDA-regulated medical device context.

• Manage project planning and execution from initial concept through to launch.

• Ensure compliance with design control, manage schedules, assess risks, allocate resources, oversee budgets, and facilitate decision-making processes.

• Collaborate with R&D, Regulatory Affairs, Quality, Clinical Affairs, Operations, Marketing, Finance, and external development partners to establish project scope, objectives, and deliverables.

• Create precise and attainable project plans and timelines, effectively communicating these to team members and leadership.

• Foster team ownership and commitment to project plans, recommending adjustments as necessary.

• Monitor and report on project performance, evaluating progress towards short- and long-term goals.

• Ensure timely completion of project tasks in alignment with project and company procedures.

• Facilitate meetings with cross-functional project teams.

• Carry out additional responsibilities as assigned.

⛳️ Requirements

• A Bachelor’s degree in science, engineering, business administration, or a related field is required; an advanced degree is preferred.

• A minimum of 5 years of project management experience leading cross-functional product development projects.

• Direct experience in managing FDA-regulated medical device product development projects.

• Proficient understanding of medical device design control requirements and product development processes, including design planning, design reviews, and risk management.

• Experience with in vitro diagnostic (IVD) products, specifically in assay and/or diagnostic instrument development, is preferred.

• Familiarity with Quality Management Systems compliant with FDA 21 CFR Part 820 and relevant medical device regulations is preferred.

• Project management certification (PMP) or equivalent is preferred.

• Proven project management skills with substantial practical experience, ideally in the diagnostics or related biotechnical field.

• Demonstrated success in managing products from concept through to launch.

• Ability to identify critical paths.

• Strong problem-solving abilities; a self-starter with attention to detail, capable of prioritizing and balancing workloads and timelines while managing multiple projects concurrently.

• Capacity to work independently as well as collaboratively with peers and colleagues in a cross-functional environment.

• Highly organized, able to meet tight deadlines and perform effectively under pressure in a fast-paced work setting.

• Excellent interpersonal, organizational, written, and verbal communication skills.

• A basic understanding of device development, engineering, and manufacturing processes is an advantage.

🏝️ Benefits

• Option for remote work.

• 20% travel as necessary to support project teams and key milestones.