Senior Director of Product Development

Overview

A large medical device manufacturing client in Maplewood is looking to add to their leadership team! This Senior Director of New Product Development will play a pivotal role in developing and shaping the future of the engineering department. This person will be tasked with not only growing the team but also developing medical products, implementing enterprise-wide business processes and leading the team.

This person will need to engage with customers to establish clear technical expectations, lead the team to execute innovative complex catheter designs from concept to manufacturing transfer, and provide cross-functional leadership to ensure effective costing/quoting, scope management, program management, Phase-Gate process compliance and smooth and effective transfer-to-manufacturing.

• 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.

• 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

Salary of $180,000 - $200,000 with bonus and benefits