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 assays and diagnostic instrument systems within an FDA-regulated medical device framework.

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

• Ensure compliance with design control, schedules, risk management, resources, budget constraints, and facilitate clear decision-making processes.

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

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

• Foster team ownership and commitment to project plans, suggesting modifications as needed.

• Monitor and report on project performance, analyzing the achievement of both short- and long-term objectives.

• Ensure timely completion of project tasks and adherence to company procedures.

• Facilitate cross-functional project team meetings.

• Travel as necessary to support project teams and critical milestones.

• Execute additional responsibilities as assigned.

⛳️ Requirements

• A Bachelor’s degree in science, engineering, business administration, or a related field is mandatory.

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

• Hands-on experience 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.

• Proven project management capabilities with a successful track record in practical project management, ideally in the diagnostic or related biotechnical sector.

• Evidence of effective management of product(s) from concept to market launch.

• Capability to identify critical paths.

• Strong problem-solving skills; self-motivated, detail-oriented, with the ability to prioritize and manage workloads and timelines, while handling multiple projects concurrently.

• Ability to work both independently and collaboratively with peers and colleagues in a cross-functional environment.

• Highly organized with the capacity to meet tight deadlines and perform well under pressure in a dynamic work setting.

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

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

• Willingness to travel up to 20% of the time.

🏝️ Benefits

• Option for remote work.

• Required travel to support project teams and key milestones.

• 20% travel commitment.