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Senior Project Manager – Medical Product Development

Nextern · Cartago

Senior 🇬🇧 English
Project Management Product Development Equipment Qualification Process Validation

Descripcion del puesto

About the role

The Senior Project Manager will lead new process‑product development projects from concept through commercialization, ensuring alignment with customer specifications and internal standards. This role combines hands‑on product solution design with cross‑functional coordination to deliver high‑quality medical devices at optimal cost.

Key responsibilities

  • Coordinate new product development activities with customers and internal teams.
  • Create and track schedules, budgets, resource plans, and performance targets for engineering deliverables.
  • Provide visibility on schedule and budget issues, manage escalations, and resolve critical project challenges.
  • Facilitate cross‑functional communication between engineering, supply chain, manufacturing, and business development.
  • Review designs, determine bill of materials, and obtain pricing from internal and external vendors.
  • Draft quotations and project scopes for management review and customer delivery.
  • Support component and device testing, equipment qualification, and process validation.
  • Guide pilot production across multiple manufacturing sites and ensure successful stage‑gate completion.
  • Maintain complete documentation for Design History Files and production records.

Required profile

  • Bachelor’s degree in Engineering, Business Administration, or a related field.
  • At least five years of experience in the medical industry, including project management responsibilities.
  • Minimum of four years in a technical role such as Process or Product Development R&D engineering (preferred).
  • Proven ability to manage complex, cross‑functional projects and meet regulatory compliance standards.

Required skills

  • Project Management
  • Product Development
  • Process Development
  • Medical Device Engineering
  • Bill of Materials Management
  • Supply Chain Coordination
  • Equipment Qualification
  • Process Validation

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