Posted in General Business 30+ days ago.
Type: Full-Time
Location: West Lafayette, Indiana
Project Manager 1- Biocompatibility, Toxicology, Material Science
Requisition ID 2024-14205
Posting Date 22 hours ago (7/9/2024 8:00 PM)
Job Location(s) West Lafayette IN United States
Position Type Full Time
Company Cook Research Inc.
Category Clinical
Overview
We are seeking a highly motivated and experienced Research & Development 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;
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; and
Experieince in biocompatability requirements of medical devices based on ISO 10993 and FDA guidance is preferred.
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"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.
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