Job Description

Essential duties and responsibilities:

• Establish overall team direction and goals, and effectively assess resources toward completion of goals, in conjunction with Senior Leadership in both R&D and Operations. Promote an open, collaborative environment focused on teamwork
• Manage the NPI team, including technical oversight, professional development and hiring qualified colleagues
• Partner efficiently with R&D for developing or improving manufacturing process, e.g. assembly automation
• Define and implement process control and process capability analysis
• Manage new device test method validation and manufacturing process validation
• Work with manufacturing teams on technology and new process implementation
• Apply standard project management tools, processes and principles to ensure NPI project success, ensure that sound decision making principles and agreements are followed and develop team agreements
• Build, gather and share updated information and documentation on what requirement there is to product design set by production and allow robust planning with Procurement and Supply Chain
• Serve as advocate and role model for integrating change into the organization as well as serve as departmental role model for continuous improvement in speed and quality.

• Demonstrated experience in people management and leadership role at least 5 years
• 8+ years in a R&D or Operations role, including NPI experience
• Bachelor\xe2\x80\x99s or advanced degree in engineering
• 8+ years experience in regulated industry preferably FDA and knowledge of design control guidelines
• Experience of Innovation, Development and Qualification as relates to New Product Introduction
• Ideally familiar to ISO13485 or 21 CFR 820

• Robust Project Management skill with expertise influencing key decision makers within a matrix environment
• Problem Solving \xe2\x80\x93 Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.
• Robust learning agility \xe2\x80\x93 ability to digest information quickly, apply existing knowledge, make connections across different areas, and identify questions/areas to explore
• Strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner.