Project Manager 1 Biocompatibility, Toxicology, Material Science

Overview

We are seeking a highly motivated and experienced Project Manager to join our dynamic team. The ideal candidate will possess strong leadership skills, an understanding of research and development processes, a track record of successfully managing complex projects from conception to completion, as well as a scientific background and the ability to apply science-based critical thinking to contribute to projects and solve problems. This individual will play a crucial role in driving innovation, managing resources efficiently, and ensuring the successful execution of research and development initiatives.

The position will be responsible for support of the Central Engineering Services group, including the biocompatibility/toxicology/materials science team, with projects related to the safety and regulatory approval of medical devices. This may include technical and scientific aspects, and will be focused on project management and various other support, such as ensuring that cross-functional teams (e.g., engineers, scientists, and other professionals) are appropriately informed and coordinated.

Responsibilities

Collaborate and clearly communicate with internal and external stakeholders to ensure appropriate planning, and execution of biocompatibility assessments, tests and other activities;

Provide support for Cook Medical leadership in accordance with company policies, procedures, applicable laws, and regulations that apply to the job activities;

Interact with and support various groups, locally and globally, across Cook Medical, including Engineering, Regulatory Science, Regulatory Affairs, and others;

Use project management skills to help organize work tasks, milestones, and due dates for multiple concurrent projects:

• Project Planning and Strategy: Develop and implement project plans, timelines and strategies for research and development initiatives that align with the company business plan, and collaborate with cross-functional teams to define project goals, objectives, and key deliverables;
• Resource Management: Assist in allocating resources effectively to ensure project milestones are achieved on time and within budget, and identify and propose solutions for potential resource constraints or bottlenecks;
• Communication: Facilitate effective communication within the project team and with key stakeholders, and provide regular updates on project progress, milestones achieved and challenges faced;
• Innovation and Continuous Improvement: Encourage a culture of continuous improvement and innovation within the R&D team, and stay abreast of industry trends, emerging technologies and competitive landscapes to help drive innovation.
• Collaboration with External Partners: Facilitate collaboration with external stakeholders including customers, vendors, academic institutions and contract research organizations, to leverage expertise and resources;
• Provide responsive and proactive organizational and administrative support to team members and collaborators;

Apply critical thinking and scientific reasoning to contribute to projects and solve problems, including helping ensure that biocompatibility assessments comply with ISO 10993 standards and FDA guidance documents;

Utilize project management tools to help organize the various requests for biocompatibility evaluation and to ensure timely completion of assessments, testing, reports and associated documentation;

Maintain effective communication with cross functional teams and stakeholders;

Proactively address issues as they arise, working closely with team members to find solutions; and

Develop and maintain a working knowledge of relevant QMS processes and procedures, regulations (e.g., EU MDR), and standards (e.g., ISO 10993, ISO 17025).

Qualifications

A minimum of a Bachelor's degree (scientific-, health-, or business-related field preferred) plus relevant experience is required;

Proficient in the following skill sets: time management, leadership, written and verbal communication, problem-solving;

Capability to handle multiple dynamic projects and responsibilities;

Ability to exercise sound judgment in interdependent decision making;

Outstanding work ethic and strong personal discipline;

Ability and desire to work in a collegial team atmosphere, including communicating and working constructively with colleagues and stakeholders;

Research or project management background is preferred;

Experience in biocompatability requirements of medical devices based on ISO 10993 and FDA guidance is preferred;

This role requires founational literacy in Artificial Intelligence (AI) and data concepts, including the ability to explain these conceps simply, identify appropirate uses of AI in daily work, responsibly use approved AI tools for low-risk tasks, and consistently apply Cook Medical''s data privacy and responsible AI guidelines; and

Qualified candidates must be legally authorized to be employed in the United States.  Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.