Primary Function of Position:
Deliver significant improvements in product reliability, cost, manufacturability, capacity, and serviceability for robotic surgical instruments and accessories.
The Process Engineer is responsible for leading continuous improvement projects, maintaining the plant layout, time studies, balancing production lines, maintaining standard time for all products among other industrial and OPEX related activities.
Roles and Responsibilities:
This position has responsibility and authority for:
• Leading continuous improvement projects.
• Coaching and providing training on continuous improvement tools and methodologies. DMAIC, root cause analysis, SPC, other statistical techniques, etc.
• Time studies to determine standard time and line balancing.
• Maintaining the plant layout to improve productivity and capacity.
• Productivity improvement activities.
• Waste reduction activities.
• Facilitate kaizen events.
• Elaborate VSM of critical processes.
• Lead initiatives focused on yield improvement, material cost reduction.
• Update documents as needed to maintain compliance with the quality system.
• Ensure proper documentation is generated (investigation, addressing of root cause, and reporting) for any variances, or concerns on all aspects of the manufacturing process through current notification processes (VR’s, NCR’s, PL’s, etc.)
• Coach and participate in supplier selection for mechanical parts.
• Coach and lead engineering in the implementation of assembly lines or product transfers into our facilities, including planning, validation/verification and final implementation.
• Performs other duties as required.
• Travel: Position may require 5-10% travel, primarily within U.S.
Competency Requirements: (Competency is based on: education, training, skills and experience.)
In order to adequately perform the responsibilities of this position the individual must:
• Be of high character and energy with regard for detail.
• Excellent communication skills, both written and verbal in English and Spanish. Able to communicate eloquently up, down, and sideways.
• Demonstrate leadership skills to coordinate and coach other employees in continuous improvement activities.
• Demonstrate Lean Manufacturing and Six Sigma Green Belt knowledge.
• Demonstrate Process Engineering ability.
• Demonstrate ability in root cause analysis and continuous improvement.
• BS degree in Industrial/Mechanical/Electrical/Electronic Engineering or equivalent.
• Minimum 2 years mechanical, manufacturing or process engineering experience with Mid/high volume of complex mechanism manufacturing.
• Able to read and understand mechanical and electrical drawings.
• Schedule oriented and demonstrate results based on such schedules (Plans / Gantt charts)
• Possess strong communication skills to interact with suppliers and other departments within the company (product development, planning, purchasing, regulatory, quality, etc…)
• MS in an engineering discipline.
• Prior experience working in an FDA/ISO regulated environment.
• Experienced in ISO 13485 or medical device manufacturing environment.
• Prior responsibility for process, equipment or product validation/verification.
• Prior experience with automated equipment, complex mechanism manufacturing, or robotics.
• Machine tool experiences a plus.
• Experience with ASME Y14.5 Geometric Dimensioning and Tolerance.
• Experience in Just-In-Time, Demand Flow Technology, and Lean Manufacturing techniques.
High English Level (+ 90 %).