NPI Manufacturing Engineer

About the role

The primary function of this position is to contribute technical manufacturing and equipment design skills to a dynamic development team. The role involves creating, maintaining, and improving manufacturing lines, designing fixtures and tools, validating processes, and providing technical support.

Responsibilities

• Create, maintain, and improve “low to mid-volume” manufacturing lines, specifying and/or refining BOMs, workflow processes, manufacturing plans, and detailed work instructions.
• Develop and document PMC processes for newly introduced fixtures and tools.
• Analyze manufacturing lines from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
• Validate and qualify manufacturing equipment and processes to production status using standard qualification approaches (IQ/OQ/PQ).
• Provide production support of sustaining and startup manufacturing lines as needed.
• Conduct testing of software releases before deploying on manufacturing lines.
• Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement, and cost reduction.
• Contribute to the establishment of group and individual objectives consistent with overall product development goals, including planning, priority setting, establishing metrics, and effectively communicating progress.
• Maintain connections with leading manufacturing equipment suppliers and stay updated on the latest state-of-the-art processes and equipment.
• Execute and mentor others in manufacturing process validations, process FMEAs, and other elements associated with production master validation plans.
• Maintain compliance with medical device quality system including corrective action closure and change order implementation.
• Contribute to the establishment of group and individual objectives consistent with overall product development goals, including planning, priority setting, establishing metrics, and effectively communicating progress.
• Provide resource planning and budget estimates for product and process improvements, tooling development, and testing.

Requirements

• Prior experience with managing product and process changes.
• Diligent organizational skills and proven ability to simultaneously work on several fast-paced projects.
• Strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support, and clinical marketing teams.
• Proven technical, analytical, and troubleshooting skills.
• Minimum BS degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or similar relevant experience.
• Minimum 4 years of experience as a design or manufacturing engineer supporting product with significant mechanical, electromechanical, or electro optical content.

Qualifications

• Must have experience releasing new product or manufacturing line through design/build process to production.
• Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support, and clinical marketing teams.
• Must have proven technical, analytical, and troubleshooting skills.
• Minimum BS degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or similar relevant experience.
• Minimum 4 years of experience as a design or manufacturing engineer supporting product with significant mechanical, electromechanical, or electro optical content.