Principal Responsibilities
• Lead/Support continuous improvement initiatives for design control and risk management processes
• Identify and eliminate process inefficiencies using operational excellence tools
• Develop training materials to foster a culture of operational excellence
• Ensure processes align with regulatory requirements for medical device and drug combination products (e.g FDA 21 CFR Part 820, ISO 13485, ISO 14971)
• Collaborate with cross-function teams to improve processes related to device-drug integration.
• Partner with Quality and Regulatory teams to ensure compliance with applicable global regulations
• Leverage data analytics and key performance indicators to monitor process performance.
Position Qualifications:
Education Minimum Requirement:
• B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus 7 years of related experience or Master's degree in one of the above disciplines plus 5 years related experience
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Required Experience and Skills:
• 5+ years of experience in process improvement, Quality management system, operational excellence.
• Has broad knowledge of medical device development, design controls and risk management
• Hands-on experience with combination products
• Proven track record of driving lean and six sigma initiatives in a regulated environment
• Led and managed development of DHF (design history file) deliverables for medical devices
• Knowledge of U.S. and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.
• Self-motivated and work independently.
• Proven ability to work with team members of diverse skill sets and backgrounds.
• Strong analytical and problem solving abilities.
• Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership.
• Excellent communication, presentation, negotiation, project management, and organizational skills
Preferred Experience and Skills:
• PMP or similar project management certification
• Quality Engineering Certification
• Six Sigma Certification
• Experience with device design, requirement management, FMEA, design verification, design validation, statistical sampling, and control strategy.
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