Sr Director, New Product Development

VitalPath•Saint Paul, MN

3d•$160,000 - $200,000•Onsite

About The Position

The Senior Director, New Product Development will play a pivotal role in developing and shaping the future of our Engineering Team specifically and the business generally. They will be tasked with not only recruiting, retaining and nurturing top talent but also developing breakthrough medical products, implementing enterprise-wide business processes and leading a dynamic team to success. This role is a critical one in driving alignment and integration across the organization with specific core responsibilities including engaging with customers to establish clear technical expectations, leading the team to execute innovative complex catheter designs from concept to manufacturing transfer, and providing cross-functional leadership to ensure effective costing/quoting, scope management, program management, Phase-Gate process compliance and smooth and effective transfer-to-manufacturing. This is not a lead from behind the desk role, it requires a hands-on approach for both team leadership and overall execution.

Requirements

Bachelor’s Degree in Mechanical, Biomedical, Industrial, or other relevant Engineering required
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
Experience in defining budgets and schedules for projects
Firm understanding of process validation (IQ, OQ, PQ) strategy
Experience with design controls, FDA regulation, GMP, GDP and QMS requirements
Demonstrated excellent written and oral communication skills
Travel as needed based on business needs
Must be able to work with a microscope and sit and/or stand for an extended period of time
Must be able to lift 25 pounds

Responsibilities

Pipeline Growth: Collaborate with Commercial Teams to identify and secure new business opportunities, leveraging your technical expertise and industry insights to support business growth and expand our market presence.
Team Leadership: Lead the recruitment, development, and management of the NPD Engineering Team; fostering a culture of catheter expertise, customer collaboration, rapid response, successful development and design transfer into Operations.
Culture: Further develop and maintain a culture of internal and external stakeholder collaboration.
Training: Ensure the NPD Team has training necessary to excel at their jobs.
Succession Planning: Coach and develop team members to ensure proper bench strength and succession planning.
New Technology: Enhance VitalPath’s overall 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.
Product and Process development Excellence: Drive product and process development to align with internal (Phase-Gate) and external (ISO 13485) process guidelines and effectively address customer needs.
Problem Solving: 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.
Design Transfer: Work cross functionally to ensure a smooth transfer of new products into Operations. This role is critical in ensuring the NPD Engineering Team does the necessary product and process development to enable a smooth Transfer-to-Manufacturing.
All other duties as required.