Sr. R&D Technician

Position Summary

The Sr. R&D Technician is responsible for assisting R&D Engineers in the design, development, testing, documentation, and manufacturing of new and existing products.

Principal Responsibilities

•    Facilitate and support implementation of Engineering DV pilot lines, and PVAL Production lines for R&D, including planning, setup, and training of Manufacturing operators. 
•    Create, revise, and maintain (CO, ECO) of Manufacturing Process (MP), Travelers (RT), special work orders (SWO), Test Methods (TM), and Inspection Methods (IP) for Engineering builds
•    Coordinate with Operations/Production and Test Lab for Engineering builds: Characterization, DV, PVAL for prototyping, building, and testing for R&D project teams. 
•    Accurately document Engineering builds including process inputs, process controls, boundary conditions and testing results. Responsible for controlling related reports and results. e.g. (CO, ECO).  
•    Facilitate and coordinate: design, building, purchasing, testing, calibration, installation & qualification (IQ) for equipment, tooling, manufacturing aids, gauges, and inspection equipment for R&D
•    Drive 5S improvements in R&D labs organization and processes.
•    Responsible for maintaining lab equipment, qualification, calibration, maintenance, replacement, etc. 
•    Responsible for maintaining safety and training procedures in R&D labs to ensure safe operation of lab equipment.  
•    Identify, investigate, troubleshoot design input specifications, process/quality defects, and manufacturing challenges.  Suggest and implement solutions to new product development challenges, using Engineering tools such as, failure analysis and root cause analysis. 
•    Understand and apply risk mitigation activities identified in Process risk documents (DFMEA/PFMEA).
•    Compile and analyze measurement and testing data results using Excel, Mini-Tab, or other statistical software.
•    Support manufacturing line continuous improvement strategies to improve quality, reduce cost, minimize waste, and increase throughput.  

Note: 75% of this job involves direct R&D activities.
 

Education / Experience Requirements

•    High School Diploma/GED required; Associates or technical degree in manufacturing technologies/engineering preferred.
•    7+ years of experience in design and development of medical devices preferred.
•    4+ years of experience using Oracle Agile PLM software or equivalent preferred.
 

Specialized Skills / Other Requirements

•    Proficient in MS Office applications.
•    Excellent oral and written communication skills. Proficient at communicating effectively across functions to achieve common goals.
•    Ability to manage dynamic workload and prioritize small and large tasks efficiently.
•    Working knowledge and experience implementing Good Manufacturing Practices (GMP).
•    Advanced knowledge of technologies related to catheter design and construction, such as extrusion, injection molding, adhesive, thermal bonding, welding, core winding, and reflow processing.
•    Experience with and working knowledge of ISO9000, FDA requirements.
•    Working knowledge of mechanical drawings, product requirements and engineering specifications.
•    Attention to detail. Ability to manipulate small pieces of data with accuracy and focus, identifying information that does not fit and implement solutions.
•    High mechacial aptitude and strong problem solving/decision-making skills. Ability to think criticaly and implement solutions independently.
•    Competencies - incumbent must have proven abiilty to:
o    Instills Trust - Gains the confidence and trust of others through honesty, integrity, and authenticity. Follows through on commitments; is seen as direct and truthful; keeps confidences; practices what he/she teaches; shows consistency between words and actions.
o    Courage - Steps up to address difficult issues, saying what needs to be said. Readily tackles tough assignments; faces difficult issues and supports others who do the same; provides direct and actionable feedback; is willing to champion an idea or position despite dissent or political risk.
o    Decision Quality - Makes good and timely decisions that keep the organization moving forward. Makes sound decisions, even in the absence of complete information.
o    Plans and Aligns - Plans and prioritizes work to meet commitments aligned with organizational goals. Sets objectives to align with broader organizational goals; breaks down objectives into appropriate initiatives and actions; stages activities with relevant milestones and schedules; anticipates and adjusts effective contingency plans.
o    Cultivates innovation - Creates new and better ways for the organization to be successful. Comes up with useful ideas that are new, better, or unique; introduces new ways of looking at problems; can take a creative idea and put it into practice; encourages diverse thinking to promote and nurture innovation.
o    Optimizes Work Processes - Knows the most effective and efficient processes to get things done, with a focus on continuous improvement. Identifies and creates the processes necessary to get work done; separates and combines activities into efficient workflow; designs processes and procedures that allow managing from a distance; seeks ways to improve processes, from small tweaks to complete reengineering.

TRAVEL REQUIRED: 5%
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