Integra LifeSciences
Project Manager
Integra LifeSciences, Princeton, New Jersey, us, 08543
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.We are seeking a dynamic and detail-oriented individual to join our team as a Project Specialist, focusing on EU MDR compliance in accordance with Design Control. This role involves developing, coordinating, and implementing improvements, specifically in the area of labeling, in alignment with regulatory standards and plant procedures.Primary responsibilities are to:
Support project teams by facilitating the circulation and approval of Design Control documents in adherence to global Design Control Procedures, contributing to the success of the projects.Assist the Program Management and Labelling organizations in driving project activities, managing specific project tasks and workstreams with a focus on successful project delivery.Engage with cross-functional teams, including Division and Site Management and Engineering, to ensure seamless coordination of manufacturing capabilities, production schedules, and documentation.Leadership role in small sustaining projects including setting goals, managing timelines, and conducting project team meetings under the supervision of Program Management leadership.Utilize Project Management tools to oversee projects, ensuring the timely achievement of objectives while meeting cost and quality requirements.Plan, design, and coordinate the seamless integration of equipment into the manufacturing process, including its qualification and validation.Perform assigned duties with a proactive mindset, taking initiative, and adapting to the evolving needs of the team and organization.Education:
BS Degree in Engineering, Physical or Life Sciences desired.Experience:
7+ years of experience in product development and/or project management.Experience within matrix organizations.Experience with medical products preferred.Experienced with ISO and FDA quality systems regulations and medical design and development cycles.
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Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.We are seeking a dynamic and detail-oriented individual to join our team as a Project Specialist, focusing on EU MDR compliance in accordance with Design Control. This role involves developing, coordinating, and implementing improvements, specifically in the area of labeling, in alignment with regulatory standards and plant procedures.Primary responsibilities are to:
Support project teams by facilitating the circulation and approval of Design Control documents in adherence to global Design Control Procedures, contributing to the success of the projects.Assist the Program Management and Labelling organizations in driving project activities, managing specific project tasks and workstreams with a focus on successful project delivery.Engage with cross-functional teams, including Division and Site Management and Engineering, to ensure seamless coordination of manufacturing capabilities, production schedules, and documentation.Leadership role in small sustaining projects including setting goals, managing timelines, and conducting project team meetings under the supervision of Program Management leadership.Utilize Project Management tools to oversee projects, ensuring the timely achievement of objectives while meeting cost and quality requirements.Plan, design, and coordinate the seamless integration of equipment into the manufacturing process, including its qualification and validation.Perform assigned duties with a proactive mindset, taking initiative, and adapting to the evolving needs of the team and organization.Education:
BS Degree in Engineering, Physical or Life Sciences desired.Experience:
7+ years of experience in product development and/or project management.Experience within matrix organizations.Experience with medical products preferred.Experienced with ISO and FDA quality systems regulations and medical design and development cycles.
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