Principal PD Project Management Specialist - PH - Fridley/Rice Creek, MN (Onsite)

About the role

This role serves as the Operations leader for cross-functional New Product Introduction (NPI) teams, driving the successful transfer of new products into manufacturing. The role requires strong leadership, influence, and program management skills to align stakeholders, navigate complexity, and bring innovative Neuromodulation and Pelvic Health therapies to patients worldwide.

Responsibilities

• Lead Operations strategy and execution for NPI programs, driving cross-functional teams to launch new products into manufacturing.
• Establish and manage key metrics, including product cost, yield, capacity, process capability, and risk reduction.
• Develop Design Transfer plans, reports, and supporting commercialization documentation.
• Partner with stakeholders to define manufacturing strategies, including: Manufacturing site selection, Distribution strategy, Contract manufacturing scope, Capacity and capital planning, Process validation strategy, Supplier selection, Pilot line and production scale-up activities.
• Manage Operations plans, budgets, schedules, resources, and cross-functional dependencies.
• Lead Extended Operations teams to deliver programs on time, within budget, and in compliance with quality, regulatory, and NPD requirements.
• Execute and continuously improve Operations strategies that support successful product launches.

Qualifications

• Bachelor's degree required with minimum of 7 years of engineering experience in manufacturing and/or product development, or
• Advanced degree with a minimum of 5 years of engineering experience in manufacturing and/or product development, or
• PhD degree with minimum of 3 years of engineering experience in Manufacturing and/or product development.

• Nice to Have:
• Advanced degree in Engineering, Operations, or a related technical field; MBA preferred.
• Experience in medical device product development and/or manufacturing, with knowledge of applicable FDA, ICH, and IEC regulations and standards.
• Demonstrated experience supporting products throughout the full product lifecycle, from development through commercialization and sustainment.
• Certification in Design for Six Sigma (DFSS), Design Reliability Management (DRM), or Six Sigma Green Belt preferred.
• PMP certification or equivalent project management credentials strongly preferred.
• Proven Operations experience with expertise in one or more areas, such as Manufacturing Engineering, Supply Chain, Quality, Contract Manufacturing, or Operations Program Management.
• Experience within highly regulated industries, including medical devices, pharmaceuticals, aerospace, or automotive.
• Strong background in structured problem-solving, root cause analysis, and continuous improvement methodologies.
• Experience planning and executing manufacturing process validation activities.
• Demonstrated project engineering and/or program management experience in new product development, manufacturing, or commercialization environments.