Manufacturing Engineer - Systems
About The Position
The entry-level Manufacturing Engineer - Systems supports multiple manufacturing lines for mature and new instruments and accessories for the Ion platform. The role supports existing lines, recommends and implements improved manufacturing processes, and leads manufacturing line transfers. It requires effective collaboration across Quality, Design, and Manufacturing teams in the United States and Mexico. The engineer leads manufacturing line transfer projects across two plants, including project scheduling, equipment procurement and qualification, documentation improvement, knowledge transfer, and troubleshooting electromechanical equipment. The position also supports Ion manufacturing lines by improving product reliability and process flows, introducing fixtures and equipment, conducting validations and process risk analyses, providing design-for-manufacturing input, managing production capability, and supporting failure investigations. The role maintains compliance with the medical-device quality system and works with Quality and Regulatory to follow applicable GMP, design history file, and device history record guidelines under FDA requirements. It also contributes to team objectives, metrics, project prioritization, progress communication, and resource budget estimates. The position requires 25% travel, including international travel. It is a day-shift role and is described as onsite weekly, with the percentage of onsite work defined by the leader.
Requirements
- Strong technical problem-solving and analytical skills.
- Familiarity with component manufacturing processes such as machining, injection molding and MIM, stamping, coining, and extrusion.
- Familiarity with mechanical CAD software, specifically SolidWorks.
- Familiarity with Process and Equipment Qualifications (IQ/OQ/PQ/PPQ).
- Strong organizational skills and ability to manage several fast-paced projects simultaneously.
- Ability to communicate effectively and professionally with cross-functional peers, executive leadership, internal customers, and external suppliers.
- Bachelor of Science degree in an engineering discipline.
- Ability to travel 25%, including internationally.
Nice To Haves
- Master's degree in an engineering discipline.
- Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials, and stress analysis.
- Prior experience with Design Control processes for medical devices, clinical applications of surgical instruments, and/or automated equipment design.
Responsibilities
- Lead manufacturing line transfer projects, including coordinating project schedules across multiple functions and two plants.
- Procure, assemble, and qualify custom mechanical and electromechanical equipment.
- Improve equipment documentation and design to support continuous improvement and future transfers.
- Develop expertise in manufacturing processes and transfer that knowledge remotely to new engineers and assemblers.
- Troubleshoot electromechanical equipment, collaborating with third-party equipment makers as needed.
- Maintain regular communication with production teams to support short- and long-term needs.
- Manage product reliability improvements from concept through implementation.
- Identify, design, qualify, document, and introduce assembly and test fixtures and equipment.
- Improve manufacturing process flows to optimize reliability, efficiency, capacity, cost, and technician safety.
- Execute and mentor others in manufacturing process validations, process FMEAs, and other production Master Validation Plan activities.
- Provide product and process Design for Manufacturing/Assembly input and lead improvement implementations.
- Manage manufacturing strategy and production capability for Ion instrument lines to minimize customer backorders.
- Maintain medical-device quality-system compliance, including corrective action closure, discrepant material disposition, and Engineering Change Order implementation.
- Provide technical support for failure analyses and root-cause investigations of product failures.
- Contribute to group and individual objectives, priority setting, metrics, and progress communication.
- Estimate resource budgets for product and process improvements, tooling development, and testing.
- Work with Quality and Regulatory to ensure compliance with applicable GMP, DHF, and DHR guidelines per FDA requirements.
Benefits
- Market-competitive compensation package including base pay, incentives, benefits, and equity.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
