Engineering Program Manager (Medtech)

TL;DR

Engineering Program Manager (Medtech): Leading and coordinating cross‑functional engineering programs for the Villalba site with an accent on product development, lifecycle management, and regulatory compliance. Focus on managing program scope, schedule, costs, and risks for initiatives such as scrap reduction, yield improvement, and equipment obsolescence.

Location: Onsite in Villalba, Puerto Rico, USA. Candidates must possess unrestricted U.S. work authorization (sponsorship is only available for Principal-level roles and above).

Company

A global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Lead the planning, execution, and governance of engineering programs from concept through commercialization and sustainment.
• Develop and maintain detailed program plans, schedules, budgets, and resource forecasts.
• Coordinate cross‑functional teams including Engineering, Quality, Regulatory Affairs, Manufacturing, and Supply Chain.
• Ensure program execution complies with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971 standards.
• Identify, assess, and mitigate program risks through robust contingency plans and monitoring.
• Manage program changes via formal change control processes and maintain regulatory artifacts like DHF and DMR.

Requirements

• Bachelor’s degree in engineering or a related technical discipline.
• Minimum of 5 years of relevant experience (or 3 years with an advanced degree).
• Experience managing complex engineering programs in the medical device, pharmaceutical, or regulated manufacturing industry.
• Strong knowledge of product development processes, design controls, and regulatory requirements (FDA, ISO).
• Proficiency with program management tools such as MS Project, Smartsheet, and Agile/Waterfall methodologies.
• Must have unrestricted U.S. work authorization.

Nice to have

• 7–10 years of progressive experience in engineering or program management.
• Professional certifications such as PMP or PgMP.
• Familiarity with validation processes (IQ/OQ/PQ) and design transfer to manufacturing.
• Experience working within global, matrixed organizations and with external stakeholders.

Culture & Benefits

• Competitive salary and flexible benefits package.
• Eligibility for the hirify.global Incentive Plan (MIP) short-term incentive.
• A mission-driven environment focused on healthcare access and equity.
• Opportunities for lifelong career exploration and innovation in a global team.