Costa Rica-Heredia
Hybrid Roles:
About the Role:
Leads design changes originating from product or yield improvements, Regulatory or supply chain needs. Develops new technologies, products, materials, processes, or equipment with minimal supervision.
Your Responsibilities Include:
- Develops technology, product designs, testing of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
- Lead product improvement design activities
- Designs, coordinates, analyzes complex engineering tests and experiments.
- Develops slide decks & reports and presents updates to management & technical community.
- Influences middle management on business solutions.
- Interfaces with physicians, Marketing and/or field personnel to obtain feedback on concepts and performance of new devices.
- Translates customer needs into product requirements and design specifications.
- Partners with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure success.
- May train and/or provide work direction to technicians and entry-level engineers.
- Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors.
- May lead projects within the function or department and/or represent a specialized field in larger project teams.
- Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to manager.
- Conduct root cause analysis of design related field complaints
- Support RA team with new markets registrations and regulatory submissions.
What we're looking for
- e: >5 years
- English level: 80-89% or above
- Licenciature: Mechanical, Electromechanical, Biomedical or related field
- Master degree desirable
- Problem solving
- Technical and Clinical Knowledge
- Networking
- Design control methods such as Risk Analysis (dFMEA, pFMEA)
- Design, Validation and Verification plans, protocol, and report generation.
- Medical Devices Industry experience
- PDP/TDP System
- Preferred Project management
- Please submit Resume in English