Cypress HCM · 5 days ago
Senior Director of New Product Development
Cypress HCM is a large medical device manufacturing company seeking a Senior Director of New Product Development to enhance their leadership team. This role involves developing medical products, implementing business processes, and leading a team to execute complex catheter designs from concept to manufacturing transfer.
Responsibilities
Enhance technical capability by seeking out and putting together a business case for new technologies and coordinating a Technology Roadmap which aligns with the strategic focus of the company
Drive product and process development to align with internal and external (ISO 13485) process guidelines and effectively address customer needs
Engage and lead cross functional teams to address design, product and process requirements, utilizing effective planning and problem-solving methodologies and subject matter experts to optimize processes and outcomes
Work cross functionally to ensure a smooth transfer of new products into Operations
Ensure the NPD Engineering Team does the necessary product and process development to enable smooth Transfer-to-Manufacturing
Collaborate to identify and secure new business opportunities, leveraging your technical expertise and industry insights to support business growth and expand our market presence
Lead the recruitment, development, and management of the NPD Engineering Team
Foster a culture of catheter expertise, customer collaboration, rapid response, successful development and design transfer into Operations
Ensure the NPD Team has training necessary to excel at their jobs
Coach and develop team members to ensure proper bench strength and succession planning
Qualification
Required
Bachelor's Degree in Mechanical, Biomedical, or other relevant Engineering
Minimum of 15 years working in a catheter or medical component development and manufacturing environment, with a focus on product and process design
Minimum of 10 years supervision experience
Firm understanding of process validation (IQ, OQ, PQ) strategy
Experience with design controls, FDA regulation, GMP, GDP and QMS requirements
Experience in defining budgets and schedules for projects
Benefits
Bonus
Benefits