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Senior Project Engineer - Medical Device Product Transfer

Medtronic · San Isidro

New
Senior 🇬🇧 English
Microsoft Project ISO 13485 FDA regulations GMP

Job description

About the role

Medtronic, a global healthcare technology company, is looking for a Senior Project Engineer to lead end-to-end medical device product transfer projects. The role ensures compliance with FDA, ISO 13485 and applicable regulatory requirements, and involves working closely with engineering, operations, quality, supply chain and R&D teams.

Key responsibilities

  • Lead end-to-end medical device product transfer projects in compliance with FDA, ISO 13485 and applicable regulatory requirements.
  • Develop and maintain integrated project plans with timelines, milestones, resource requirements and budget baselines.
  • Build, manage and monitor critical path schedules in Microsoft Project, tracking progress and driving on-time delivery.
  • Facilitate collaboration across engineering, operations, quality, supply chain and R&D teams.
  • Identify, assess and mitigate project risks and develop contingency plans.
  • Remove technical and operational roadblocks and accelerate issue resolution.
  • Provide technical leadership and engineering expertise for critical project decisions, process improvements and manufacturing readiness.
  • Present project status, risks, accomplishments and recommendations to senior leadership and key stakeholders.

Required profile

  • Bachelor's degree in Engineering or a related technical discipline with at least 3 years of relevant experience, or a Master's degree with at least 2 years of experience in medical devices.
  • 3+ years leading engineering projects in a regulated medical device, life sciences or highly regulated manufacturing environment.
  • Experience managing product transfers, manufacturing process implementation or production scale-up.
  • Demonstrated experience leading cross-functional teams and managing project risks, timelines and deliverables.

Required skills

  • Advanced proficiency with Microsoft Project, including scheduling, critical path management and resource planning.
  • Preferred: PMP, CAPM, Scrum Master or similar project management certification.
  • Preferred: knowledge of FDA regulations, ISO 13485, GMP and medical device design transfer requirements.
  • Preferred: experience presenting to executive leadership and stakeholder management across global organizations.

What we offer

  • Competitive salary and a flexible benefits package.
  • Eligibility for the Medtronic Incentive Plan (MIP).

Questions fréquentes

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Published 3 hours ago

Expires 1 month from now

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Medtronic

San Isidro