Sr. Measurement Process Development Engineer

Johnson & Johnson - Danvers, MA

Full-time - Senior

Danvers, MA

Chemical Manufacturing

About the position

The Senior Measurement Process Development Engineer at ABIOMED, part of Johnson & Johnson MedTech, is a pivotal role focused on developing and implementing measurement processes for high precision components made from metal, ceramic, and plastic. This position is essential for the company's growth and innovation in the medical technology sector, particularly in the area of heart recovery and life-saving solutions. The engineer will serve as the in-house expert, leveraging their technical expertise to enhance measurement processes that support the introduction of new components. In this role, the engineer will evaluate existing measurement processes and implement necessary improvements to ensure accuracy and efficiency. They will also be responsible for training technicians and operators on the use of new measurement tools and processes, ensuring that the team is well-equipped to maintain high standards of quality. The engineer will draft and complete gauge R&R protocols, IQ/OQ/PQ protocols, and engineering change orders, which are critical for maintaining compliance in regulated environments. Collaboration is key in this position, as the engineer will work closely with internal partners to design and implement fixturing, gauges, and templates that support inspection measurement processes. Additionally, they will engage with suppliers to align measurement process development with ABIOMED's internal standards. The engineer will also assist in analyzing defective components during inspection and reinforce best practices for gauge use across the team. This role offers a unique opportunity to make a significant impact in a fast-growing company dedicated to advancing medical technology and improving patient outcomes.

Responsibilities

• Develop and implement measurement processes to support the introduction of new components.
• Evaluate current measurement processes and develop improvements as necessary.
• Train or oversee the training of technicians and operators in the use of new measurement tools, fixtures, and processes.
• Draft and complete gauge R&R protocols and reports, IQ/OQ/PQ protocols and reports, and engineering change orders.
• Develop and/or collaborate with internal partners to design and implement fixturing, gauges, and templates for inspection measurement processes.
• Work with suppliers to support measurement process development as necessary, ensuring alignment with ABIOMED's internal processes.
• Partner with Supplier Engineering and Development Engineering to complete project deliverables to meet program milestones.
• Assist in the analysis of defective components at incoming inspection.
• Reinforce current best practices for gauge use.
• Collaborate with a broad team of engineers and technicians to meet job objectives.

Requirements

• Bachelor's Degree, preferably in Mechanical, Plastics, or Manufacturing Engineering.
• 5+ years of professional work experience, preferably in medical devices or other regulated high precision manufacturing environments.
• Proven experience programming and operating CMM and vision systems; experience with MicroVu CMM is a plus.
• Proven experience drafting and completing IQ/OQ/PQ protocols and reports.
• Proven experience drafting and completing Gauge R&R studies.
• Lean Six Sigma Green Belt required; Black Belt preferred.
• Working knowledge of metrology tools.