Senior Product Development Program Manager (NPI)

MiniMed•San Diego, CA

3d•Onsite

About The Position

The Senior Product Development Program Manager (NPI) will lead cross-functional efforts supporting the deployment, validation, manufacturing readiness, and commercialization of next-generation product platforms. This individual will serve as the primary program leader coordinating Operations, Manufacturing Engineering, Quality, Regulatory, Supply Chain, Sourcing, and Contract Manufacturing partners to achieve successful operational readiness and product launch objectives. The role requires strong program management skills, manufacturing transfer experience, and the ability to drive alignment across internal and external stakeholders to deliver program milestones, validation activities, manufacturing readiness, and launch execution.

Requirements

Bachelor's degree and minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.
Experience leading cross-functional development or manufacturing transfer programs.
Experience working with contract manufacturers and equipment suppliers.
Experience coordinating equipment development, manufacturing readiness, process validation, and production launch activities.
Ability to influence stakeholders and drive execution without direct authority.
Proven ability to manage complex schedules, risks, budgets, and stakeholder communications.
Strong leadership, collaboration, and influence skills.
Medical device or regulated industry experience.
Knowledge of IQ/OQ/PQ, FAT/SAT, and manufacturing readiness processes.
Manufacturing transfer, process validation, and commercialization experience.
Experience supporting automated manufacturing equipment deployment.
PMP certification or equivalent program management experience.

Nice To Haves

Bachelor's degree in Engineering, Operations, Life Sciences, or related field.

Responsibilities

Lead planning and execution of manufacturing deployment activities for new product production lines.
Develop and manage integrated project plans, schedules, milestones, dependencies, and critical path activities.
Coordinate cross-functional teams to ensure alignment on scope, timeline, budget, and deliverables.
Drive program reviews and communicate status, risks, mitigation plans, and key decisions to leadership.
Drive alignment on program priorities, readiness criteria, resource requirements, and launch strategies.
Coordinate equipment requirements, design, procurement, build, testing, FAT, SAT, installation, commissioning, and qualification activities.
Partner with Manufacturing Engineering, R&D, Quality, and Operations teams to ensure equipment and process readiness.
Support manufacturing line capacity planning, staffing strategies, operator training, and production ramp plans.
Coordinate development of manufacturing documentation, work instructions, training plans, procedures, and readiness deliverables.
Facilitate timely resolution of equipment, tooling, fixture, automation, and process issues across suppliers, contract manufacturers, and internal teams.
Coordinate execution of validation plans including IQ, OQ, PQ, and associated readiness activities.
Partner with Quality and Regulatory teams to ensure compliance with applicable standards and procedures.
Support development and closure of risk assessments, validation deliverables, and readiness documentation.
Ensure program deliverables meet quality, compliance, and commercialization requirements.
Drive alignment between equipment readiness, process validation, product testing, and manufacturing release activities.
Partner with contract manufacturers to establish integrated deployment plans, governance, execution priorities, and performance expectations.
Coordinate sourcing, supplier readiness, material availability, component qualification, logistics, and capacity planning activities.
Partner with Supply Chain and Sourcing teams to identify and mitigate launch, capacity, and continuity-of-supply risks.
Support resolution of supplier, material, and manufacturing constraints that could affect validation, ramp, or commercialization.
Maintain alignment between internal teams, equipment suppliers, and contract manufacturing partners.
Establish and maintain program risk registers, mitigation plans, decision logs, and escalation processes.
Build strong partnerships across R&D, Operations, Manufacturing Engineering, Quality, Regulatory, Supply Chain, Sourcing, Finance, and Commercial organizations.
Lead resolution of technical, operational, quality, supply chain, and schedule risks impacting program execution.
Facilitate cross-functional decision-making and drive closure of critical issues and readiness gaps.
Align stakeholders around program objectives, timelines, dependencies, and expected business outcomes.
Drive cross-functional launch readiness activities across Operations, Supply Chain, Quality, Regulatory, and Commercial teams.
Support production ramp activities and post-launch stabilization.
Monitor launch metrics and facilitate timely resolution of manufacturing and supply chain issues.
Ensure successful transition from project execution to sustained operations.
Deliver program milestones on schedule and within approved budget targets.
Ensure successful completion of validation and regulatory deliverables.
Identify and proactively manage program risks, issues, and dependencies.
Achieve equipment, process, manufacturing, and operational readiness for commercial production.
Drive launch readiness, production ramp, capacity attainment, and post-launch stabilization.
Maintain alignment between internal stakeholders, suppliers, and contract manufacturing partners.
Balance schedule, cost, quality, capacity, and compliance requirements throughout program execution.