Senior Manufacturing Engineer

We are seeking a Senior Manufacturing Engineer to enhance our medical device clients engineering team. In this role, you’ll collaborate closely with manufacturing technicians and maintenance personnel to refine existing processes, ensuring they align with our clients stringent quality standards and meet customer demands. The Senior Manufacturing Engineers contributions will play a pivotal role in driving efficiency, safety, and excellence across operations.

Requirements of the Senior Manufacturing Engineer:

• Bachelor’s degree in Engineering.
• 6+ years industry experience in mechanical or manufacturing or process engineering
• Experience with ISO13485 and cGMP regulations preferred.
• Proven ability to prioritize tasks, take ownership, and achieve results in a challenging environment.
• Strong communication skills across all organizational levels.
• Familiarity with statistics, process control tools, and Integrated Lean Six Sigma Work Systems preferred.
• Knowledge of machining skills
• Authorization to work in the US without sponsorship.

Responsibilities of the Senior Manufacturing Engineer:

• Participate in the planning, execution, and analysis of test protocols and experiments for new and revised products and processes, including process validations.
• Contribute to the documentation and updating of standard operating procedures, working closely with operators to identify areas for improvement.
• Provide timely resolution to product, process, and equipment issues through innovative short and long-term solutions.
• Offer technical support and troubleshooting assistance for manufacturing and extrusion operations.
• Monitor manufacturing variances to identify improvement opportunities and prepare comprehensive reports on process performance.
• Ensure compliance with relevant QA/RA standards, including ISO13485 and cGMP regulations, throughout all projects and processes.
• Support audits related to GMP, safety, ISO, and internal protocols.