Project Manager II – Medical Device

About the role

ECIECI is seeking a Project Manager II to lead cross‑functional projects throughout the product lifecycle of regulated medical devices. You will coordinate engineering, manufacturing, quality, regulatory, and supply‑chain teams to ensure timely, on‑budget delivery while meeting all quality and regulatory standards.

Key responsibilities

• Develop and maintain integrated project plans, schedules, budgets, milestones, and resource allocations.
• Coordinate activities across Engineering, Manufacturing, Quality, Regulatory, Validation, and Supply Chain stakeholders.
• Manage equipment, process documentation, tooling, and knowledge‑transfer activities.
• Track validation, qualification, change control, risk management, and production‑readiness tasks.
• Identify, resolve, and escalate project risks, issues, and dependencies.
• Oversee pilot builds, validation runs, production ramp‑up, and site readiness.
• Provide regular status, financial, and risk reports to leadership.
• Ensure successful hand‑off to the receiving manufacturing site and close out projects.

Required profile

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• At least 8 years of overall experience with 6+ years in project management, preferably in medical device, pharmaceutical, biotechnology, or regulated healthcare.
• Strong knowledge of FDA regulations, ISO 13485, and risk‑management principles.
• Proven ability to lead cross‑functional teams and manage multiple projects simultaneously.
• PMP or equivalent certification preferred.
• Advanced written and verbal English communication skills.

Required skills

• Agile project methodology
• Waterfall project methodology
• Microsoft Project
• Jira