Principal Process Engineer - Johnson and Johnson

Abiomed, a part of Johnson & Johnson is currently recruiting for a Principal Process Engineer to be located in Danvers, MA or Aachen, Germany.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Abiomed, a division of Johnson and Johnson Medtech is a pioneer and global leader in healthcare technology, dedicated to transforming the lives of patients with advanced heart failure. Our innovative medical devices and groundbreaking therapies empower healthcare professionals to provide life-saving solutions and improve patient outcomes. As we continue to push the boundaries of medical innovation, we are seeking a dynamic and experienced Principal Process Engineer to join our team at our Danvers, MA headquarters.

Abiomed is seeking a highly skilled and motivated Principal Process Engineer to provide technical guidance and leadership within our global process engineering Team, withing 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 technical Mind with a deep understanding of Scientific and Data driven process engineering principles, and a passion for driving excellence in medical device manufacturing.

Key Responsibilities:
• Technical Leadership: Act as a key technical leader in the process development and engineering space. Leading initiatives to support process and SOP improvement while upskilling existing team members, and supporting the implementation of 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: Act as a mentor for all team members•• Bachelor's degree in engineering or related field; advanced degree (Master's or Ph.D.) preferred.
• Minimum of 10 years of experience in process engineering within the medical device or pharmaceutical industry required.
• Strong background in implementing scientific and data-driven process development methodologies required.
• Experience with Lean/six sigma methodologies required (Black belt preferred)
• 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.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.