Project Manager - Biocompatibility, Toxicology, Material Science

Project Manager 1 - Biocompatibility, Toxicology, Material Science

Requisition :
Posting Date: 6/16/2026 5:37 PM

Location:

West Lafayette, IN, United States
Position Type:
Full Time
Company:
Cook Research Inc.

We seek an experienced Project Manager to lead and support the Central Engineering Services biocompatibility/toxicology/materials science team. The role involves managing complex research and development projects, ensuring regulatory compliance with ISO 10993 and FDA guidance, and coordinating cross‑functional teams across engineering, regulatory science, and regulatory affairs.

• Collaborate and communicate with internal and external stakeholders to plan and execute biocompatibility assessments, tests, and related activities.
• Provide support for Cook Medical leadership in accordance with company policies, procedures, applicable laws, and regulations.
• Interact with and support various local and global groups across Cook Medical, including Engineering, Regulatory Science, Regulatory Affairs, and others.
• Use project management skills to 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:
  Allocate resources effectively to ensure project milestones are achieved on time and within budget, 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, staying 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 ensure biocompatibility assessments comply with ISO 10993 standards and FDA guidance documents.
• Utilize project management tools to organize biocompatibility evaluation requests and 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.
• Develop and maintain a working knowledge of relevant QMS processes, regulations (e.g., EU MDR), and standards (e.g., ISO 10993, ISO 17025).

• Minimum of a Bachelor's degree in a scientific, health, or business-related field.
• Proficiency in time management, leadership, written and verbal communication, and problem‑solving.
• Capacity to handle multiple dynamic projects and responsibilities.
• Judgment in interdependent decision‑making.
• Strong work ethic and personal discipline.
• Ability and desire to work in a collegial team atmosphere, communicating constructively with colleagues and stakeholders.
• Research or project management background preferred.
• Experience with biocompatibility requirements of medical devices based on ISO 10993 and FDA guidance preferred.
• Foundational literacy in Artificial Intelligence (AI) and data concepts, including the ability to explain these concepts simply, identify appropriate uses of AI in daily work, responsibly use approved AI tools for low‑risk tasks, and apply Cook Medical’s data privacy and responsible AI guidelines.
• Must be legally authorized to be employed in the United States;
  Cook does not sponsor work visas.

We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class. Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state, province, and local law.