Knowledge & Skills:
• Special Skills:
o Demonstrated ability to lead team activities
o Strong ability to coach
o Advanced critical thinking & problem-solving skills
o Strong communication, presentation, follow-through, and organizational skills
o Ability to effectively work both vertically and horizontally across the organization and cross functionally
o Collaboration and conflict resolution skills
• Specialized Knowledge:
o Knowledge of current FDA, ISO, MDD, and other related quality and regulatory system requirements that intersect with design control and product development activities
o Comprehension of product & process development engineering principles sufficient to allow participation in product and technology development program ideation, scoping, initiation, and execution
o Broad experience base with manufacturing processes across multiple products and processes, preferably inclusive of medical components, subassemblies and finished medical devices
o Able to travel domestically and internationally, as required (up to 30% at times)