Lead Mechanical Engineer

• Lead Mechanical Engineer
  possessing strong technical judgment and a deep understanding of customer centric design to support new product development from concept to production.

The incumbent may be asked to perform other function-related activities in addition to the below mentioned as responsibilities as reasonably required by business needs.

This position is responsible for performing the following tasks as assigned while receiving strategic supervision with assignments:

• Provides technical leadership for new product development (NPD) mechanical work streams and projects, accountable for technical quality, cost, schedule, and delivery of milestones.
• Leads mechanical development from concept through design transfer and product launch, including product architecture, subsystem definition, interface management, design decisions, and risk management.
• Leads development of product frames and skins, balancing structural performance, weight, appearance, cleanability, serviceability, manufacturability, and cost.
• Leads mechanical design of electromechanical interfaces, including integration of components such as pumps with the console structure, mechanisms, electrical systems, and fluid pathways.
• Leads design of interfaces between reusable consoles and disposable components, such as FMS Flo Paks, addressing alignment, connection, retention, usability, leak prevention, and reliable operation.
• Translates customer, user, regulatory, and system requirements into mechanical design inputs, acceptance criteria, and verification plans.
• Establishes mechanical design strategies, technical plans, budgets, schedules, and resource needs; communicates status and escalates risks and issues as appropriate.
• Drives value engineering and cost reduction against product cost targets. Evaluates design, materials, manufacturing processes, suppliers, tooling, and assembly methods; documents savings and verifies that changes preserve product requirements.
• Leads design for manufacturing and assembly with internal manufacturing teams and suppliers, considering processes such as machining, casting, sheet-metal fabrication, injection molding, and plating.
• Coordinates mechanical design with electrical, EMC, systems, quality, regulatory, human-factors, and other functions, including enclosure shielding, bonding, and plating strategies where required.
• Leads technical reviews, facilitates decisions on complex design tradeoffs, and presents recommendations, risks, and supporting data to project teams and stakeholders.
• Provides technical direction to engineers and project contributors; coordinates work, reviews deliverables, and mentors and develops less-experienced engineers.
• Leads prototype builds, engineering investigations, and verification and validation activities; uses test results and root-cause analysis to resolve issues and guide design improvements.
• Leads design-transfer and production-readiness activities, including supplier engagement, process and inspection planning, documentation, and resolution of build issues through launch.
• Prepares, reviews, and approves mechanical design deliverables and project documentation for technical completeness, quality, and applicable standards.
• Evaluates new technologies, materials, methods, and engineering processes that may improve product performance, manufacturability, reliability, or cost.
• Contributes to project proposals and business planning by developing or reviewing technical scope, estimates, schedules, and resource requirements.

• N/A

• Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, or a related field with research and development experience in the medical device industry.

• 8-…