Senior Project Engineer - Medical Device Product Transfer
Medtronic · San Isidro
Descripcion del puesto
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).
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Publicado hace 3 horas
Expira en 1 mes
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Medtronic
San Isidro