R&d Project Engineer

hace 6 meses

Tecate, México Teleflex A tiempo completo

**About Teleflex Incorporated**

**Surgical -** Whatever the latest surgical breakthrough looks like, Teleflex is working to make it happen. From our MiniLap® Percutaneous Surgical System to Weck® Hem-o-lok® Polymer Locking Ligation System, and Weck EFx® Shield Fascial Closure System, our portfolio of products adds up to a powerful offering of solutions that helps improve patient outcomes. These innovative, mínimally invasive surgery products are offered alongside time-tested and trusted Pilling® Surgical Instrument and Lightsource solutions to provide a comprehensive set of solutions to meet the challenges of an evolving healthcare environment. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

**Position Summary**:
**Principal Responsibilities**:
1. As an integral part of the project team, provides design, manufacturing, supply, timing, and assembly expertise to projects.
2. Provide support to project management for sample/product acquisition required for aging, packaging, ship test, sterilization, customer labs, samples, other.
3. Managing operations-related communications, upward and downward through the organization; escalating key issues and presenting options for resolution to the Senior Leadership Team.
4. Responsible for managing validation schedules including IQ/OQ/PQ, product production within agreed upon scope, budget, timeline, and quality.
5. Working with project management, ensure all components/documents are properly placed into SAP and Agile.
6. Generate test protocols, analyze test data, and generate written reports.
7. Contribute to design documentation including input for the Design History File (DHF) and technical design reviews.
8. For in house manufactured and purchased components, plan and lead the verification and validation activities for new/replacement components.
9. Individually deliver or guide technical resources in the development/improvement of products and processes, optimize by utilizing tools such as Design Of Experiment (DOE), accomplish their evaluation through verification and validation, and assist in their implementation with appropriate controls and metrics.
10. Meet project objectives, milestones, and target dates. Update and review project progress on an as-required basis by supervisor.
11. Direct the efforts of draftsmen, technicians, tradesmen, and lab personnel in the development of test fixtures, equipment, test procedures and documentation.
12. Lead and participate in design and technical phase reviews.
13. Ensure projects are developed and documented in compliance with the Teleflex Quality System.
14. Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards.

**Education / Experience Requirements**:

- Prefer Bachelor level degree in Engineering / Technology or equivalent experience in medical device operation, planning and new product introduction
- At least 2 years minimum engineering experience within a medical device environment
- Experience working with manufacturing suppliers preferred
- Excellent communication, presentation, and multi-functional departmental leadership
- A comprehensive understanding of ISO, GMP and FDA regulations
- Experience in the commercialization of medical devices in U.S., globally is preferred
- Project Management Skills perferred

**Specialized Skills / Other Requirements**:
1. Orientation for detailed work with emphasis on accuracy and completeness
2. Effective written and oral communication skills
3. Good organizational and planning skills; drives for results
4. Effective analytical/problem solving skills
5. Good interpersonal skills that include working well in a team environment and the ability to lead others.
6. Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
7. Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision.
8. Working knowledge of international requirements and quality systems.
9. Computer Literate: Microsoft Office - PC, Word, Excel, PowerPoint
10. Willingness to travel out of country as required

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