You would be part of an agile new product development team for the Endoscopy division that focuses on delivering high revenue products to the business. Your main development team is collocated in Coyol manufacturing site to enable quick decision making and proximity to manufacturing lines.
Designs and develops new technology, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects. Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.
Your Responsibilities Include:
Consistently generates innovative and unique solutions to market needs and submits idea disclosures. Work is expected to result in the development of new or refined products, processes, or equipment.
Successfully completes complex engineering work in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
Selects techniques to solve complex problems and make sound design recommendations.
Summarizes, analyzes, and draws conclusions from complex test results.
Designs and prepares complex reports to communicate results to technical community.
Designs and coordinates complex engineering tests and experiments.
Documents project goals and progress and recommends appropriate revisions.
Prepare documentation for regulatory submission.
Prepare design documentation to be reviewed in Design Reviews as part of the product development process.
Present, explain and defend technical decisions and assumptions during Design Reviews.
Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment.
Interfaces with physicians/cath Lab personnel to obtain feedback on concepts and performance of new devices.
Translates customer needs into product requirements and design specifications.
Responsible for engineering documentation.
Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success.
Demonstrates PDP/TPD system knowledge through delivery of high quality and high impact deliverables.
Works under general direction regarding the direction and progress of projects and special assignments.
Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors.
Participates in determining goals and objectives for projects.
Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations. Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to manager.
What We’re Looking For:
Desirable experience: 4 years
Preferred English level: 80-89%
Bachelors Licenciature Degree: Mechanical, Electromechanical, Biomedical or related field
Problem solving
Technical and Clinical Knowledge
Networking
Statistical analysis
Part creation
SW/Capture (desire)
Risk taking mentality
Open communication
Creativity
Attention to detail
Challenging mindset
Collaborative
Proactive
Experience in design controls and development of DHR and DMR. Required understanding of interdependencies between design documentation raging from Hazard Analysis, Task Analysis, Design Requirements, Design Controls, Design Verification and Design Validation.
Or an equivalent combination of education and experience