Engineering Program Manager (CTOR) - PH - Fridley/Rice Creek, MN (Onsite)

About the role

This role serves as the primary Operations leader for cross-functional New Product Introduction (NPI) teams, driving the successful transfer of new products into manufacturing.

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 5 years of engineering experience in manufacturing and/or product development, or
• Advanced degree with a 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