We believe in taking care of our people so they can take care of others. As a global, family-owned company that has been improving patients’ lives since 1963, we’re committed to doing business with integrity and making a positive impact in the communities where we live and work. We’re guided by strong ethical standards and core values, and we believe the best ideas come from creating solutions together. Our company culture values every voice, brings together inclusive teams who collaborate well, and encourages learning and innovation. When you join Cook, you’re not just starting a job, you’re building a career with purpose, in a company that invests in you.
What You Can Expect at Cook These are some ways we support our people across Cook:
· Meaningful work & strong values: Contribute to improving patient care globally in a company known for high ethical standards and integrity.
· Competitive rewards & security: Competitive, performance-related compensation and benefits that support your health and financial wellbeing.
· Flexibility & time off: Paid time off, holidays, and hybrid or remote work options for many jobs, where possible.
· Growth & development: Learning opportunities, educational assistance, and development programs to help you grow your skills and career.
· Wellbeing & community: Health and wellness initiatives, social activities, and community engagement that help you feel connected and supported.
Benefits and programs vary by country and job. Our recruiters can provide more information about the specific benefits and programs available in your location.
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.
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:
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).
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.
At Cook, we are building our future on Invention, Connection, People, and Community.
As a privately owned company, we can look at the world our own way and do what we feel passionate about. What are we passionate about? That’s simple: Making unique, quality products and connecting with people to improve lives on both sides of the device.
Central to our focus on building deep connections is our belief in the importance of identifying innovative solutions to help customers, patients, employees, and communities thrive. We understand that our ongoing success will come from creating inclusive, supportive, and healthy environments where we can prosper together. Our people are our greatest asset and are at the heart of everything we do. Come build with us.
