Principal Process Engineer

Johnson & Johnson - Danvers, MA

Full-time - Principal

Danvers, MA

Chemical Manufacturing

About the position

Abiomed, a division of Johnson & Johnson Medtech, is seeking a highly skilled and motivated Principal Process Engineer to join our team at our Danvers, MA headquarters. This position is pivotal in providing technical guidance and leadership within our global process engineering team, specifically focusing on Global New Product Introduction. The successful candidate will play a crucial role in implementing data-driven process development and engineering best practices to optimize manufacturing processes for new product introductions and drive transformative process improvements in existing processes. The Principal Process Engineer will be responsible for leading initiatives that support process and Standard Operating Procedure (SOP) improvement while upskilling existing team members. This role requires a strong technical mind with a deep understanding of scientific and data-driven process engineering principles, as well as a passion for driving excellence in medical device manufacturing. The candidate will also be expected to implement and promote the use of data analytics to drive decision-making processes, leveraging statistical methods and process monitoring tools. Collaboration is key in this role, as the Principal Process Engineer will work closely with Research and Development (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. The successful candidate will also be responsible for developing and implementing best practices in process development and engineering, staying abreast of industry trends and advancements to ensure the highest standards of quality and efficiency in our manufacturing processes.

Responsibilities

• Act as a key technical leader in the process development and engineering space.
• Lead initiatives to support process and SOP improvement while upskilling existing team members.
• Support the implementation of a structured approach to process development.
• Lead efforts to optimize new and existing manufacturing processes through scientific and data-driven methodologies.
• Ensure efficiency, scalability, and compliance with regulatory standards in manufacturing processes.
• Implement and promote the use of data analytics to drive decision-making processes.
• Leverage statistical methods and process monitoring tools for process optimization.
• Collaborate closely with R&D, Quality Assurance, Regulatory Affairs, and other cross-functional teams.
• Integrate process engineering principles into product development and ensure alignment with regulatory requirements.
• Develop and implement best practices in process development and engineering.

Requirements

• Strong technical background in process engineering principles.
• Experience in medical device manufacturing.
• Proven ability to lead process optimization initiatives.
• Expertise in data analytics and statistical methods.
• Strong collaboration skills to work with cross-functional teams.
• Ability to implement best practices in process development.

Nice-to-haves

• Experience with regulatory compliance in medical device manufacturing.
• Familiarity with advanced manufacturing technologies.
• Knowledge of Lean and Six Sigma methodologies.