Education and Experience:
B.S. and 5+ years of medical device experience Excellent understanding of structured problem solving tools (e.g. DMAIC, Six Sigma, Black Belt)
Expertise in validation of medical device manufacturing processes and equipment
Expertise in data analysis tools such as DOE and process development
Experience and capability working collaboratively under a Quality Management System (QMS), ISO 13485 preferred
The ability to analyze data using various operating systems and programs and to develop intra-department teams to establish goals and take corrective actions to improve performance.
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Preferred Skills and Competencies:
A combination of education, training, and experience that results in demonstrated competency to perform the work may be substituted
Hands-on technical ability with assembly methodologies including locational methods, assembly setup, pneumatic actuators, servo motors, limit switches, sensors, robotics, etc.
Mechanical aptitude, technical ability, ability to read and understand technical drawings and manuals.
Technical knowledge of cam driven linkages, discrete component assembly, and automation
Familiarity with machine user interfaces (HMIs / GUIs)
Have strong interpersonal and communication skills
Excellent attention to detail, organizational skills, and rigorous process discipline
Thirst for knowledge and intense curiosity
Decision Making – has a systematic and methodical approach to making decisions, seeks out and explores relevant information, thinks creatively beyond the immediate problem, assimilates facts quickly, challenges assumptions, and considers business implications of potential solutions. Communication Skills – Conveys information effectively, actively listens, resolves conflict constructively. Work Organization – Takes a structured, economical approach to resources including time, people, money, and equipment. Problem Solving – Uses a systematic, methodical approach to gather facts, define problems, generate, and implement solutions. Initiative – Makes decisions and takes actions appropriately. Willing to take risks as circumstances require. Planning Skills – Sets goals and priorities, thinks ahead, and identifies activities and resources needed to achieve goals. Perseverance – Achieves objectives by overcoming difficulties through tenacity and resilience.
Physical Requirements:
Thirst for knowledge and intense curiosity
