MicroVention is now Terumo Neuro

Manager, Product Transfer Project - CR

Position Overview

Lead and own the end-to-end transfer of new and existing medical device products across Terumo Neuro sites, including transfers from R&D to manufacturing and between manufacturing facilities. Accountable for the planning, execution, and successful delivery of transfer programs, ensuring compliance with design transfer requirements, regulatory standards (FDA 21 CFR 820, ISO 13485), and internal Quality Management System procedures. Establish and drive transfer governance, including development of transfer agreements, project plans, resource allocation, and risk management to ensure execution aligned with defined scope, timelines, and business objectives. Ensure readiness and completion of all validation and qualification activities (IQ/OQ/PQ), manufacturing documentation, and training required to support a successful production ramp-up. Lead cross-functional and cross-site teams (Engineering, Quality, Supply Chain, Production, and Regulatory) to resolve risks, remove roadblocks, and ensure alignment throughout the transfer lifecycle. Drive operational excellence by ensuring effective planning of materials, equipment, labor, and documentation, while delivering transfer outcomes on time, within budget, and meeting quality and performance targets. Job duties:
  • Lead and own end-to-end product and process transfers across sites, including new product introductions and sustaining transfers.
  • Ensure successful execution of design transfer (DHF to DMR) and manufacturing readiness.
  • Oversee development and verification of specifications, manufacturing processes, tooling, and equipment.
  • Establish and manage transfer governance framework, including transfer agreements, quality plans, and defined phases, milestone, and tollgates.
  • Develop and maintain integrated project plans covering scope, timeline, resources, and deliverables.
  • Proactively identify, assess, and mitigate risks throughout the transfer lifecycle.
  • Ensure completion of all validation and qualification activities (IQ, OQ, PQ, TMV as applicable). Ensure compliance with FDA 21 CFR 820, ISO 13485, and internal Quality Management System requirements.
  • Ensure GDP-compliant documentation and audit readiness.
  • Support or lead investigations and CAPA activities related to transfers.
  • Apply structured project management methodology (PMI-based preferred).
  • Scope, schedule, budget, and resource planning.
  • Maintain and drive project dashboards, RAID logs (Risks, Actions, Issues, Decisions), and executive reporting to leadership.
  • Ensure readiness for production ramp-up, including materials and supply continuity, equipment readiness, and workforce training and certification.
  • Accountable for transfer timelines, ramp performance (yield, scrap, efficiency), and cost vs. plan.
  • Lead cross-functional teams including Engineering, Quality, Supply Chain, and Production.
  • Lead multi-site transfers (e.g., CR ↔ AV) ensuring alignment and execution discipline.
  • Drive standardization of transfer processes, KPIs, and best practices.
  • Champion Lean, Six Sigma, and operational excellence methodologies.
  • Identify systemic gaps in transfer execution and implement improvements.
  • Drive adoption of best practices in transfer planning, documentation, and execution.
  • Lead, coach, and develop direct reports.
  • Mentor engineers, project managers, and technicians in transfer methodology.
  • Build organizational capability in transfer execution and project discipline.
  • Provide clear and structured updates to leadership on transfer progress.
  • Act as the primary point of contact for stakeholders across sites.
  • Ensure alignment across functions and timely escalation of risks and issues.
  • Adhere to QMS requirements and internal procedures.
  • Demonstrate the highest standards of ethics and integrity.
  • Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
  • Perform additional duties as assigned.

Job Details

Job ID 14031BR

Alajuela, Costa Rica

Apply for this job
    1. Bachelor’s degree in mechanical engineering, industrial engineering, electrical engineering, or related field.
    2. Minimum of seven (7) years of experience in medical device environment or similar field.
    3. Minimum of three (3) years leading end-to-end product transfers across sites.
    4. Minimum of three (3) years of experience in management capacity, overseeing teams, resources, and operational initiatives.
    5. Demonstrated experience with Process validation (IQ/OQ/PQ) and manufacturing process development and scale-up.
    6. Working knowledge of FDA 21 CFR 820, ISO 13485 and Quality Management System.
    7. Strong experience in Lean Manufacturing and/or Six Sigma methodologies.
    8. Strong written and verbal communication skills.
    9. Proficiency in statistical analysis tools, Minitab or equivalent.
    10. Demonstrated mindset of ownership, urgency, and accountability in execution.
    11. Written and verbal English proficiency (minimum B2+).
    12. Proficiency computer skills, including Excel, MS Word, Excel, Power Point, Outlook, Teams.
    13. Valid passport and Visa.
    Desired Qualifications
    1. Project Management Professional (PMP) certification or equivalent experience applying structured project management methodologies.
    2. Strong understanding of design transfer processes (DHF to DMR) and transfer governance (phase-gate, transfer agreements, quality plans).
    3. Experience operating in a highly regulated environment with strong documentation practices (GDP discipline and audit readiness).
    4. Proven ability to lead and influence cross-functional and cross-site teams in a matrix organization.
    5. Experience in driving operational improvements using Lean, Six Sigma, or continuous improvement methodologies.
    6. Strong analytical and problem-solving skills, with demonstrated ability to make data-driven decisions.
    7. Advanced proficiency in project planning and reporting tools (e.g., dashboards, project trackers).
    Physical
    • Extended periods of computer use.
    • Extended periods of sitting, standing, or speaking.
    • Light lifting, up to 25 lbs.
    • May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs).
    • International travel as required up to (50%).