Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
I Am Abiomed | I Am Heart Recovery | Patients Firs t
Abiomed is seeking a highly skilled and motivated Associate Director of Process Engineering to lead our global process engineering function within Global New Product Introduction. The successful candidate will play a pivotal role in implementing and data-driven process development and engineering best practices to optimize manufacturing processes for new product introductions and drive transformative process improvements in existing processes. This position requires a strong leader with a proven track record in managing global teams, a deep understanding of process engineering principles, and a passion for driving excellence in medical device manufacturing.
Key Responsibilities:
* Global Leadership: Provide leadership to the global process engineering team, fostering a culture of collaboration and innovation, while upskilling existing team members, selecting, and hiring new talent, and implementing a structured approach to process development.
* Process Optimization: Lead efforts to optimize new and existing manufacturing processes through the application of scientific and data-driven methodologies, ensuring efficiency, scalability, and compliance with regulatory standards.
* Data-Driven Decision Making: Implement and promote the use of data analytics to drive decision-making processes, leveraging statistical methods and process monitoring tools.
* Cross-Functional Collaboration: Collaborate closely with R&D, Quality Assurance, Regulatory Affairs, and other cross-functional teams to integrate process engineering principles into product development and ensure alignment with regulatory requirements.
* Best Practices Implementation: Develop and implement best practices in process development and engineering, staying abreast of industry trends, emerging technologies, and regulatory changes.
* Quality and Compliance: Ensure all processes adhere to regulatory standards, quality requirements, and industry best practices, with a focus on continuous improvement and risk management.
* Talent Development: Recruit, mentor, and develop a high-performing global team of process engineers, fostering a culture of learning, growth, and innovation.
Qualifications* Bachelor's degree in engineering or related field; advanced degree (Master's or Ph.D.) preferred.
* 10 years of experience in process engineering within the medical device or pharmaceutical industry.
* Proven experience in leading and managing global process engineering teams.
* Strong background in implementing scientific and data-driven process development methodologies.
* In-depth knowledge of regulatory requirements related to medical device manufacturing.
* Excellent communication and interpersonal skills with the ability to collaborate effectively across diverse teams.
* Demonstrated success in driving continuous improvement initiatives and achieving operational excellence.
* Familiarity with process development in manual, semi, and highly automated manufacturing processes.