Engineering Program Manager

Medtronic•Villalba, PR

2d•Onsite

About The Position

The Engineering Program Manager is responsible for leading and coordinating cross‑functional engineering programs for the Medtronic Villalba Site reporting to the Engineering Director. This role ensures successful planning, execution, monitoring, and delivery of complex engineering initiatives that support product development, lifecycle management, manufacturing readiness, and compliance with applicable regulatory and quality requirements. The Engineering Program Manager serves as the primary point of accountability for program scope, schedule, cost, risk, performance and capital investments for initiatives like Scrap Reduction, Yield Improvement, Programmatic Savings and Equipment Obsolescence.

Requirements

Bachelor’s degree in engineering or related technical discipline. and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
Demonstrated experience managing complex, cross‑functional engineering programs in the medical device, pharmaceutical, or regulated manufacturing industry.
Strong knowledge of product development processes, design controls, and regulatory requirements (FDA, ISO 13485, ISO 14971).
Proven ability to manage budgets, schedules, resources, and risks across multiple programs.
Excellent leadership, communication, and stakeholder management skills.
Proficiency with program and project management tools and methodologies (e.g., MS Project, Smartsheet, Agile/Waterfall/Hybrid).
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

Minimum of 7–10 years of progressive experience in engineering, program management, or project management.
Professional certifications such as PMP, PgMP, or equivalent.
Experience supporting sustaining engineering, and product lifecycle management in medical devices.
Familiarity with validation processes (IQ/OQ/PQ) and design transfer to manufacturing.
Experience working with global, matrixed organizations and external stakeholders.
Strong working knowledge of change management, CAPA, and risk management processes in regulated environments.

Responsibilities

Lead the planning, execution, and governance of assigned engineering programs from concept through commercialization and lifecycle sustainment.
Develop and maintain detailed program plans, schedules, budgets, and resource forecasts aligned with business and regulatory requirements.
Coordinate cross‑functional teams including Engineering, Quality, Regulatory Affairs, Manufacturing, Supply Chain, and external partners to ensure program objectives are met.
Drive program execution in compliance with applicable regulations and standards, including FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and internal quality system procedures.
Facilitate phase gate reviews, design reviews, and management reviews; ensure deliverables meet quality, technical, and regulatory expectations.
Proactively identify, assess, and mitigate program risks; develop and execute robust risk management and contingency plans.
Monitor program performance using established metrics and dashboards; communicate status, risks, and mitigation plans to executive leadership and key stakeholders.
Manage program changes by ensuring proper documentation, impact assessment, and approval through formal change control processes.
Support design transfer, manufacturing readiness, and validation activities, ensuring alignment with product realization and production requirements.
Ensure effective documentation management, traceability, and alignment with Design History File (DHF), Device Master Record (DMR), and other regulatory artifacts.
Collaborate with Quality and Regulatory teams to support audits, inspections, and regulatory submissions as required.
Promote continuous improvement, best practices, and program management discipline across engineering initiatives.
Mentor and support project managers and team members to strengthen program execution capabilities.
Perform other duties as assigned to support business needs.