The Project Engineer is primarily responsibility for demonstrating process feasibility in microfluidic/wound care applications while meeting quality specifications on Lightspeed ADL projects. They assist in transitioning Lightspeed ADL projects to production through the PReP process in a small team and collaborative environment. The Application Engineer must have a technical background and successful track record with expertise in project and task management skills. Project support may also include, risk management, validation activities, supporting material or supplier acquisition, and customer interface.
- Define, plan and complete Lightspeed ADL projects
- Generate high-level plans, communications, and schedules to assist with task prioritization and workload adjustments
- Proactively communicate project schedules, project change proposals and related project activities on a regular basis with customers
- Provide project guidance to Application Development Technicians and Associate Application Development Engineers
- Lead the successful transition of Lightspeed ADL projects to production
- Support the Site Director in solving on-going production issues
- Identify potential project risks and develops/implements strategies to minimize impact and control deviations from estimated costs and project deadlines.
- Support Sales through the completion quotes
- Generate and update setup sheets, work instructions, and CAPAs as required
- Take ownership of assigned tasks and work across several departments
- Lead cross departmental teams in continuous improvement processes
- Create process documentation and training where applicable (Manufacturing Process, Manufacturing, Setup, Preventive Maintenance etc.)
- Coordinate the procurement of materials, supplies, services, and controls necessary for timely and cost-effective completion of project within budget.
- Document project meeting minutes, issues log, decision log, metrics, and other key communications
- Identify resources required for project activities, develop project budgets, resource allocations and timelines
- Participate in sales support activities including sales presentations, customer visits, and technical seminars
- Other duties as assigned
- Bachelor of Science degree in an engineering/science or equivalent experience
- Familiarity with ISO Quality Systems particularly in medical device manufacturing
- Ability to generate drawings and models (2D & 3D CAD) using GD&T
- Ability to present and convey complex engineering ideas to internal and external customers
- Ability to create job related documentation for quality purposes
- Proficient with the use of optical inspection equipment. This may be defined as a magnifier, microscope, and/or equipment used for measuring capacity
- Ability to adapt quickly and positively to changing priorities and processes
- Strong communication and organizational skills
- Ability to work under minimal supervision
- Experience with industrial laser such as excimer, CO2, DPSS, ultrafast and beam deliveries
- Basic understanding of laser-material interaction for a specific application (i.e. laser processing of polymers, excimer laser- polymer, etc.) and how to apply that understanding
- Product qualification and validation experience preferably in the medical device industry Ability to generate machine motion control programs (i.e. G-Code)
- Proficient with using multiple axis motion controllers
- Experience in the medical products industry a plus
- PMP® certification beneficial but not required
- Willingness to travel
- Standing and walking for short periods of time
- Ability to use a microscope, including manipulating small object under a microscope
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Limitations and Disclaimer: The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.