Senior Engineering Program Manager - Onsite

A Day in the Life

The Pelvic Health Operating Unit develops therapies that help patients manage conditions affecting bladder and bowel control through implantable neuromodulation technologies. We work closely with product development, manufacturing, quality, supply chain, and regulatory teams to launch new products and maintain a reliable global manufacturing network.

This position is based in Minneapolis, Minnesota, and follows an onsite work arrangement. The role partners with global cross-functional teams and manufacturing sites to drive operational readiness and execution for new product introductions. Travel is not required for this position.

The Senior Engineering Program Manager serves as the Core Team Operations Representative (CTOR) and primary Operations interface to product development teams within the Pelvic Health Operating Unit. This role is responsible for leading cross-functional operations activities that support new product introduction programs, ensuring manufacturing readiness, supply chain preparedness, quality compliance, and the successful transfer of products into commercial production. This role aligns operations, manages schedule, risk, cost, capacity, and execution across the product development lifecycle.

Primary Responsibilities

• Lead cross-functional Operations teams to deliver new product introduction milestones, manufacturing readiness, and commercialization objectives.
• Represent Operations as the primary interface to product development core teams and ensure operational requirements are incorporated into program decisions.
• Develop and manage operations project plans, timelines, budgets, dependencies, risks, and performance metrics throughout the product development lifecycle.
• Define manufacturing and supply chain strategies, including site selection, make-versus-buy decisions, capacity planning, contract manufacturing scope, and business continuity considerations.
• Drive completion of design transfer activities, manufacturing scale-up plans, validation strategies, and operational deliverables required for product launch.
• Coordinate development and launch builds across manufacturing value streams while monitoring schedule performance, yield targets, and operational risks.
• Ensure compliance with quality system requirements, design history documentation, and regulatory submission support related to operations activities.
• Apply Design for Reliability, Design for Manufacturability, Lean Manufacturing, Design for Six Sigma, and related methodologies to improve product and process performance.

Required Qualifications

• Bachelor's degree with 7+ years of engineering, operations, manufacturing, supply chain, or program management experience OR Master's degree with 5+ years of engineering, operations, manufacturing, supply chain, or program management experience.
• Experience leading cross-functional projects involving product development, manufacturing transfer, or new product introduction.
• Experience managing project schedules, risks, budgets, and operational performance metrics.
• Experience working within regulated industries and quality management systems.
• Experience influencing stakeholders and leading matrixed teams without direct authority.

Preferred Qualifications

• Experience serving as a Core Team Operations Representative (CTOR) or operations lead for medical device product development programs.
• Experience with manufacturing process validation, capacity planning, and design transfer activities.
• Experience applying Design for Six Sigma (DFSS), Lean Manufacturing, Design for Manufacturability and Assembly (DFMA), or Reliability Engineering methodologies.
• Knowledge of medical device regulations, Design History Files, and commercialization requirements.
• Project Management Professional (PMP) certification and/or advanced degree in Engineering, Operations, Supply Chain, or Business.