Manufacturing Engineer, Systems

About the Role

This entry-level manufacturing engineer will support multiple manufacturing lines for both mature and new instruments and accessories for the Ion platform. The role requires the ability to collaborate effectively across functions, including Quality, Design, and Manufacturing in the US and Mexico.

Key Responsibilities

• Lead manufacturing line transfer projects, including:
• Effective project management, monitoring schedules across two plants.
• Procure, assemble, and qualify custom mechanical and electromechanical equipment.
• Improve equipment documentation and design for continuous improvement.
• Transfer manufacturing process knowledge to new engineers and assemblers remotely.
• Troubleshoot electromechanical equipment problems, collaborating with third-party equipment makers as needed.
• Support Ion manufacturing lines, including:
• Establish regular communication with the production team.
• Manage product reliability improvements from concept to implementation.
• Identify, design, qualify, document, and introduce assembly/test fixtures and equipment.
• Improve process flows of Ion instrument manufacturing lines to optimize for reliability, efficiency, capacity, cost, and technician safety.
• Execute and mentor others in manufacturing process validations, process FMEAs, and elements associated with production Master Validation Plans.
• Provide Design for Manufacturing/Assembly (DFX) input and lead improvement implementations.
• Manage manufacturing strategy and production capability for Ion Instrument lines to minimize customer backorders.
• Maintain compliance with medical device quality system, including corrective action closure, discrepant material disposition, and Engineering Change Order (ECO) implementation.
• Provide technical support for failure analyses and root cause investigations.
• Contribute to the establishment of group and individual objectives, including priority setting, metrics, and communicating progress.
• Provide resource budget estimates for product and process improvements, tooling development, and testing.
• Work with Quality and Regulatory to ensure adherence to GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements.

Requirements & Tech Stack

• Strong technical problem-solving and analytical skills.
• Familiar with various component manufacturing processes: machining, injection molding & MIM, stamping, coining, extrusion.
• Familiar with mechanical CAD software (SolidWorks).
• Familiar with Process and Equipment Qualifications (IQ/OQ/PQ/PPQ).
• Strong organizational skills and ability to work on several fast-paced projects simultaneously.
• Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials, and stress analysis is a plus.
• Able to communicate effectively and professionally with cross-functional peers, executive leadership, internal customers, and external suppliers.
• Prior experience with Design Control processes for medical devices and/or clinical applications of surgical instruments, and/or automated equipment design is a plus.
• 25% travel (including international) is required.

Qualifications

• B.S. degree in engineering discipline, M.S. preferred.